MAUDE Adverse Event Report: ARTHREX, INC. STRIPPER SEMITENDINOSUS, 7MM; ORTHOPEDIC MANUAL SURG INSTR

Model Number	STRIPPER SEMITENDINOSUS, 7MM
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/20/2023, it was reported by an arthrex subsidiary employee via (b)(4), that an ar-1278l semitendinosus stripper lost its edge and does not cut the graft, the edge of the stripper is very soft that is why it does not cut correctly.There was no additional information provided, and additional information has been requested.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Complaint allegation was not confirmed.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.Devices with cutting functions or sharp points become dull with continuous use.This condition does not indicate a device defect.This condition indicates normal wear.

• Brand Name: STRIPPER SEMITENDINOSUS, 7MM
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: emily shafer ; 8009337001
• MDR Report Key: 18348383
• Report Number: 1220246-2023-09465
• Device Sequence Number: 12317432
• Product Code: LXH
• UDI-Device Identifier: 00888867006904
• UDI-Public: 00888867006904
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

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: STRIPPER SEMITENDINOSUS, 7MM
• Device Catalogue Number: AR-1278L
• Device Lot Number: 012250
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown