FRS® Fusion and Reconstruction System Standard Staple ... - Biomet

Standard Staple
Basic Product and Instrument
Utilization Technique
®
Features and Benefits:
• Straight design
• Stainless steel construction
• Sizes include 2 mm diameter and 8 and
10 mm wide
• Dedicated instrumentation designed to
ease implant insertion
• Modular tray allows for integration with
other FRS products
• Indications: Extra-articular osteotomies of
the toe
Figure 1 Figure 2
Expose the first phalanx of the great toe through a medial
approach (Figure 1).
Note: Dotted line indicates desired orientation of correction,
not the incision.
Make two cuts close to each other using a micro-oscillating
saw, leaving the lateral cortex intact. Perform the first cut in the
metaphysis, 4-5 mm from and parallel to the articular surface.
Make the second cut in angular proportion to the desired level
of correction. After removal of the bone wedge, the assistant
maintains the proper phalangeal orientation (Figure 2).

Figure 3
Figure 4a
Figure 4b
Drill a single pilot hole cortex to cortex into the distal fragment
with the 1.0 mm diameter smooth pin (Cat. No. PA010)
(Figure 3). Depending on the distance to the metatarsal
phalangeal joint and site surface angle, the appropriate staple
(8 or 10 mm wide)) should be selected.
Note: The 1.0 mm diameter pin is marked with a black band around the
circumference of the proximal (rounded) end.
Utilize the staple holder (Straight, Cat. No. 8270-01-000) to hold
and insert the staple with its two legs parallel to the joint line
(Figures 4a and 4b). Final staple placement can be accomplished
with the appropriate staple impactor (Straight, Cat. No.
8270-03-000).
Note: Special attention should be taken not to violate the joint space.
Essential Product Information
Important This essential product information does not include all of the information necessary for
selection and use of a device. Please see full labeling for all necessary information.
Indications The standard orthopaedic staple is intended to provide the orthopaedic surgeon a
means of bone fixation and help in the general management of fractures and reconstructive surgeries.
These implants are intended as a guide to normal healing and are not intended to replace normal body
structure or bear the weight of the body in the presence of incomplete bone healing.
Contraindications This device is contraindicated: in the presence of active infection; in cases
with malignant primary or metastatic tumors which preclude adequate bone support or fixation unless
supplemental means of fixation are used; in conditions that tend to retard healing such as blood
supply limitations, previous infections etc.; if insufficient quantity or quality of bone does not permit
stabilization of the fracture complex; in conditions that restrict the patient’s ability or willingness to
follow postoperative instructions; and in cases where material sensitivity is suspected.
Warnings and Precautions This device is intended for partial weight-bearing or non-weightbearing
applications and cannot be expected to withstand the unsupported stresses of full weight
bearing. This device is not approved for attachment or fixation to the posterior elements (pedicles) of
the cervical, thoracic or lumbar spine.
Adverse Events The following are the most frequent adverse events after fixation with orthopaedic
screws: loosening, bending, cracking or fracture of the components or loss of fixation in bone
attributable to nonunion, osteoporosis, markedly unstable comminuted fractures; loss of anatomic
position with nonunion or malunion with rotation or angulation; infection and adverse reactions to the
device material.
Implants
Cat. No. Description
P106
Standard Staple, Straight 10 mm
P107
Standard Staple, Straight 8 mm
Instruments
Cat. No. Description
8270-00-000 Standard Staple Tray
8270-01-000 Standard Staple Holder, Straight
8270-03-000 Standard Staple Impactor, Straight
PA010 Smooth Pin 1.0 mm
DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, IN 46581-0988
USA
Tel: +1 (800) 366 8143
Fax: +1 (574) 371 4865
www.depuy.com
©DePuy Orthopaedics, Inc. 2011.
All rights reserved.
0612-53-050 (Rev. 4) 1.5M 0411