Medtronic SPS02411 Instructions for Use

M708348B166E Rev A

Anchor FS™ Facet Fixation System

ENGLISH

Anchor FS™ Facet Fixation System

INDICATIONS FOR USE

The Anchor FS™ Facet Fixation System is intended to stabilize the spine as an aid to fusion by
lumbar bilateral facet fixation, with or without bone graft.

This system is indicated for posterior surgical treatment of any or all of the following at L1 to S1
(inclusive) spinal levels, at single or multiple levels:

 Trauma, including spinal fractures and/or dislocations
 Spondylolisthesis
 Spondylolysis
 Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause

secondary instability or deformity

 Degenerative diseases which include degenerative disc disease (DDD) as defined by back

pain of discogenic origin as confirmed by patient history with degeneration of the disc as
confirmed by radiographic studies and/or degenerative disease of the facets with instability.

2012-08

Medtronic Sofamor Danek USA, Inc.

1800 Pyramid Place
Memphis, TN 38132, USA
Telephone [phone] (In U.S.A.)
901 396 3133 (Outside U.S.A.)
Fax [phone]

INSTRUCTIONS FOR USE

DEVICE DESCRIPTION

The Anchor FS™ Facet Fixation System is designed to provide bilateral, transfacet-pedicular
fixation of the spinal facet joint in the lumbar spine.

The Anchor FS™ Facet Screws are cannulated, and partially threaded, 4.5mm diameter screws
offered in lengths of 25-40mm (in 5mm increments). The device is composed of medical grade
Titanium. The devices are offered with a nut and a washer. The washer seats against the nut
and distributes the load placed by the nut onto the inferior articular process. The washer is
held in place during shipment with a plastic disposable retaining clip, which is removed prior to
implant of the screw, nut, and washer.

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Screw

25 mm 30 mm 35 mm 40 mm

Nut

Washer

Retaining Clip

CONTRAINDICATIONS

The contraindications include, but are not limited to:

 Active infectious process or significant risk of infection (immunocompromise)
 Signs of local inflammation
 Fever or leukocytosis
 Morbid obesity
 Pregnancy
 Mental illness
 Grossly distorted anatomy due to congenital, developmental, traumatic, previous surgery, or

severe degenerative conditions limiting anatomical definition to allow safe screw insertion

 Bone disease from osteoporosis, osteopenia, or bone resorption is a relative contraindication

since this condition limits the degree of correction and the quality of the mechanical fixation.

 Any patient lacking adequate soft tissue coverage over the operative site
 Any medical or surgical condition which would preclude the potential benefit of spinal implant

surgery, such as the presence of tumors or congenital abnormalities, elevation of
sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or
a marked left shift in the WBC differential count

 Suspected or documented metal allergy or intolerance
 Any case where metals must be mixed from different components
 Any case where the implant components selected for use would be too large or too small to

achieve a successful result

 Any case where a bone graft and fusion is unnecessary or where fracture healing is not

required

 Any patient in which implant utilization would interfere with anatomical structures or expected

physiological performance

 Any patient unwilling to follow the post-operative instructions
 Any case not described in the indications

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

WARNINGS

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 While the screw has been determined to be MR conditional, metallic instruments have not.

As such, metallic instruments are considered MR unsafe, and should not be brought into the
MR environment.

 Avoid contact of the implants of this system with other metallic and non-metallic implants to

prevent corrosion, wear, and other adverse effects

 Proper patient selection is extremely important to the eventual success of the procedure
 Correct selection of the implant is extremely important. Take into account the size and shape

of human bones when selecting the implant size. Metallic internal fixation devices cannot
withstand the activity levels and/or loads equal to those placed on normal, healthy bone.
These devices are not designed to withstand the unsupported stress of full weight or load­bearing. A higher risk of devices loosening, bending, or breaking exists with fractures
involving severe comminution, displacement, or other difficult fracture management
situations.

 These devices can break when subjected to the increased loading associated with delayed

union or nonunion. Internal fixation appliances are loaded sharing devices, which hold a
fracture in alignment until healing occurs. If healing is delayed, or does not occur, the implant
may eventually loosen, bend, or break.

 Loads on the devices produced by load bearing, and the patient’s activity level will dictate

the longevity of the implant.

 The implants may be removed after successful fusion has occurred. The surgeon should

weigh the risk versus benefit of explanation prior to implant removal through a second
surgery.

 Surgical implants must never be reused. An explanted metal implant should never be re-

implanted. Even though the device may appear undamaged, it may have small defects and
internal stress patterns which may lead to early breakage.

PRECAUTIONS

 The Anchor FS

tissues. Do not reuse, reprocess, or resterilize. Reusing this device carries the risk of
contamination and may cause patient infection or cross-infection, regardless of the cleaning
and resterilization methods. There is also an increased risk of the deterioration of the device
performance due to the reprocessing steps, which may lead to patient injury or death.

 Do not use this product if you have not been properly trained in its use. Physicians using the

Anchor FS
the selected anatomy, and be trained in the performance of the chosen technique.

 It is important to read and understand the Instructions for Use prior to use
 Do not use if package is opened or damaged because product integrity, including sterility,

may be compromised

 Do not use damaged products. Prior to use, inspect the packaging and product to verify that

no damage has occurred

 Use the Anchor FS
 The Anchor FS

guidance with radiographic equipment that provides high quality images

 If the internal fixation is not completely rigid, it is recommended the patient wear an external

splint or brace, until medical imaging confirms successful fusion of the spine level. The
patient should also be advised to reduce the stress applied to the treated region by limiting
physical activities during this period.

 Handle and dispose of this product in accordance with accepted medical practice and

applicable laws and regulations.

™

Facet Fixation System is a single use device intended to contact body

™

Facet Fixation System should be familiar with the physiology and pathology of

™

Facet Fixation System prior to the Use By date noted on the package

™

Facet Fixation System should be placed only while using fluoroscopic

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 Reconditioning, refurbishing, repair, modification, or resterilization of the product to enable

further use is expressly prohibited

 Based on fatigue testing results, when using this device, the physician/surgeon should

consider the levels of implantation, patient weight, patient activity level, other patient
conditions, etc., which may impact the performance of this system.

PREOPERATIVE

 Only patients that meet the criteria described in the indications should be selected.
 Patient conditions and/or predispositions such as those addressed in the aforementioned

contraindications should be avoided.

 Care should be used in the handling and storage of the implant components. The implants

should not be scratched or otherwise damaged. Implants should be protected during
storage, especially from corrosive environments.

 An adequate inventory of implants should be available at the time of surgery, normally a

quantity in excess of what is expected to be used.

 Since mechanical parts are involved, the surgeon should be familiar with various

components before using the equipment to verify that all parts and necessary instruments
are present before the surgery begins. The Anchor FS™ Facet Fixation System components
(described in the DESCRIPTION section) are not to be combined with the components from
another manufacturer. Different metal types should never be used together.

INTRAOPERATIVE

 Extreme caution should be used around the spinal cord and nerve roots. Damage to the

nerves can cause loss of neurological functions.

 Breakage, slippage, or misuse of instruments or implant components may cause injury to the

patient or operative personnel.

 To insert a screw properly, a guidewire should first be used. Caution: Be careful that the

guidewire, if used, is not inserted too deep, becomes bent, and/or breaks. Ensure that the
guidewire does not advance during pilot hole drilling or screw insertion. Do not use a screw
that is either too long or too large. Using an incorrectly sized screw may cause nerve
damage, hemorrhage, or the other possible adverse events listed elsewhere in this
Instruction for Use.

POSTOPERATIVE

The physician’s postoperative directions and warnings to the patient, and the corresponding
patient compliance are extremely important.

 Detailed instructions on the use and limitations of the device should be given to the patient. If

partial weight-bearing is recommended or required prior to bony fusion, the patient must be
warned that bending, loosening and/or breakage of the device(s) are complications which
may occur as a result of excessive or early weight-bearing or muscular activity. The risks of
bending, loosening, or breakage of temporary internal fixation devices during postoperative
rehabilitation may be increased if the patient is active, or if the patient is debilitated or
demented. The patient should be warned to avoid falls or sudden jolts in spinal position.

 To allow the maximum chances for a successful surgical result, the patient or devices should

not be exposed to mechanical vibrations or shock that may loosen the device construct. The
patient should be warned of this possibility and instructed to limit and restrict physical
activities, especially lifting and twisting motions and any type of sport participation. The
patient should be advised not to smoke tobacco or utilize nicotine products, or to consume

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