MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACCU-PASS STR SHUTTLE 45 DEG RGHT CRVE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	7210424
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during an acl procedure the device tip broke.A backup device was used to complete the surgery.No significant delay or patient injury reported.
Additional Manufacturer Narrative
One 7210424 accupass 45 degree suture shuttle used for treatment, was not returned for evaluation.Due to product unavailability, physical evaluation, full investigation were limited.A root cause could not be determined with confidence.Factors affecting device performance include: device ability, surgical ability and surgical site preparation according to instructions for use (ifu).Influences that could compromise product integrity include: 1) rolling the monofilament advancement roller wheels back and forth.2) inadvertent twisting or bending of the product.3) entanglement with guide wire or other instrument.4) inadvertent use of excess torque or force.5) incompatible monofilament size for specific shuttle.6) inadvertent reuse of a single use device.Per ifu: ¿it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.Read these instructions completely prior to use.As with any surgical instrument, careful attention should be exercised to assure that excessive force is not placed on the instrument.Excessive forces can result in failure of the instrument.¿ rolling the wheels forward and backward may initiate tangling or wrapping of the monofilament around the wheels.The roller wheels perform best with continuous movement in the same direction.Please note: monofilament advances with rotation of wheels in a backward direction toward the user.Keeping light tension on the tail of the filament helps the roller feed smoothly.Please note: monofilament advances with rotation of wheels in a backward direction toward the user.Keeping light tension on the tail of the filament helps the roller feed smoothly.Product met specifications upon release to distribution.
Additional Manufacturer Narrative
One 7210424 accupass 45 degree suture shuttle used for treatment, was returned for evaluation.There are scratches on the tip as with contact with another device or instrument.Integrity was compromised by force.The distal tip was distorted and split open.This typically occurs when inadvertent leverage is applied.Factors affecting device performance include: device ability, surgical ability and surgical site preparation according to instructions for use, which provides recommendations and precautionary statements and for proper use of product.Per ifu: ¿it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.Read these instructions completely prior to use.As with any surgical instrument, careful attention should be exercised to assure that excessive force is not placed on the instrument.Excessive forces can result in failure of the instrument.¿ please note: advancement of the monofilament requires backward rotation of the roller wheel toward the user.Keeping light tension on the tail of the filament assists the roller feed smoothly.Lot and complaint review were completed.Product met specifications upon release to distribution.No additional actions required at this time.

• Brand Name: ACCU-PASS STR SHUTTLE 45 DEG RGHT CRVE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9189207
• Report Number: 1219602-2019-01235
• Device Sequence Number: 19467338
• Product Code: LXH
• UDI-Device Identifier: 03596010534453
• UDI-Public: 03596010534453
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/18/2022
• Device Catalogue Number: 7210424
• Device Lot Number: 2035625
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 11/05/2019; 12/19/2019
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 11/07/2019; 01/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1