MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TENDON STRIPPER CLOSED; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	013550
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a acl clancy procedure, the surgeon stated that the tendon stripper was not cutting through tissue.The procedure was completed with a tendon stripper from arthrex.There was a delay between 5-10 minutes.No patient injury was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
One 013550 tendon stripper used for treatment, was not returned for evaluation.This is a six year old reusable product.Investigation was limited without product to evaluate.Due to product unavailability, the investigation and evaluation were limited.If objective evidence, relevant information, packaging or product becomes available to assist with evaluation, the complaint will certainly be revisited.Per the instructions for use: these instruments are designed for repeated use with proper care and handling.As with any surgical instrument, careful attention should be made to assure that excessive force is not placed on the instrument.Excessive forces applied to the instrument can result in failure.Complaint history review indicated no similar allegations for the lot number reported.Batch review did not indicate a condition or product/procedure failure that supported the allegation.Product met specifications upon release to distribution.

• Brand Name: TENDON STRIPPER CLOSED
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9560416
• Report Number: 1219602-2020-00036
• Device Sequence Number: 14037165
• Product Code: LXH
• UDI-Device Identifier: 03596010024985
• UDI-Public: 03596010024985
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2020

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 Model Number: 013550
• Device Catalogue Number: 013550
• Device Lot Number: 50520910
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 03/01/2020
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 03/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1