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

Model Number	7210424
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during a right shoulder stabilization, when the surgeon was trying to pass the accupass through the labral tissue, the tip of the accupass bent upwards blunting the end, when it was being removed from the joint, the shaft broke away from the handle.Surgeon then attempted to use a firstpass mini, then a firstpass standard and at the end doctor required to use a champion passer (stryker).It is unknown if there was a delay in the procedure, no further complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: one 7210424 accupass 45 degree suture shuttle used for treatment, was not returned for evaluation.Due to product unavailability, evaluation was limited.Ifu confirms recommendations and precautionary statements for proper use of product.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 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.Complaint history review indicated a similar allegation for the lot number reported.Batch review indicated no condition, product or procedure failure that supported the allegation.Product met specifications upon release to distribution.No additional actions required at this time.Should objective evidence become available, the complaint may be revisited.

• 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 blvd.; mansfield MA 02048
• MDR Report Key: 10176340
• Report Number: 1219602-2020-00939
• Device Sequence Number: 2560739
• Product Code: LXH
• UDI-Device Identifier: 03596010534453
• UDI-Public: 03596010534453
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/04/2022
• Device Model Number: 7210424
• Device Catalogue Number: 7210424
• Device Lot Number: 2040027
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 07/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention