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

Catalog Number	7210423
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/07/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device orange shaft broke and the metallic part detached inside the cannula.The procedure was successfully complete with a back up device.There was a 1.5 hours delay reported and no patient injuries or other complications were reported.
Additional Manufacturer Narrative
One 7210423 accupass left curve 45 degree suture shuttle used for treatment, was not returned for evaluation.A photo was sent but it was inconclusive.Due to product unavailability, physical evaluation, full investigation and conclusions were limited.Factors affecting device performance include: device ability, surgical ability and surgical site preparation according to instructions for use.Instructions for use confirms instructions, recommendations and precautionary statements and for proper use of product.Influences that could compromise product integrity include: inadvertent use of excess torque or force.Incompatible monofilament size for specific shuttle.Inadvertent twisting or bending of the product.Entanglement with guide wire or other instrument.Inadvertent reuse of a single use device.Per instruction for use: ¿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.¿ do not use these instruments as levers for manipulating hard tissue or bone.Excessive force should not be applied to the instrument when manipulating soft tissue, bone, or hard objects.Misuse of these instruments may result in bent distal tips or jaws; and dull or uneven cutting edges.¿ final product met specifications upon release to distribution.

• Brand Name: ACCU-PASS STR SHUTTLE 45 DEG LFT CURVE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9120959
• Report Number: 1219602-2019-01176
• Device Sequence Number: 11255788
• Product Code: LXH
• UDI-Device Identifier: 03596010534446
• UDI-Public: 03596010534446
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2019

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: 11/14/2021
• Device Catalogue Number: 7210423
• Device Lot Number: 2023294
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/07/2019
• Supplement Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 10/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1