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

Model Number STRIPPER SEMITENDINOSUS, 7MM

Device Problem Dull, Blunt (2407)

Patient Problem Insufficient Information (4580)

Event Date 10/23/2023

Event Type  malfunction  

Event 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.

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.

• Brand Name: STRIPPER SEMITENDINOSUS, 7MM
• Type of Device: 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
• MDR Text Key: 331067795
• Report Number: 1220246-2023-09465
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867006904
• UDI-Public: 00888867006904
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: STRIPPER SEMITENDINOSUS, 7MM
• Device Catalogue Number: AR-1278L
• Device Lot Number: 012250
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/21/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1