MAUDE Adverse Event Report: ARTHREX, INC. STRIPPER, PIGTAIL HAMSTRING TENDON, 5MM; ORTHOPEDIC MANUAL SURG INSTR

Model Number	STRIPPER, PIGTAIL HAMSTRING TENDON, 5MM
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during a surgery the stripper cut the tendo too soon.No further information was provided.Update avoe 15-oct-2024: it was further reported that the error occurred during an anterior cruciate ligament (acl) ligamentoplasty type 3+2 (didt with external return).The surgery was finished successfully by switching the surgical technique, because the surgeon couldn't do the external return as the graft was too short.It was not necessary to do a second surgery.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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 cause for the reported failure can be attributed to user error of the device due to misaligned insertion.

• Brand Name: STRIPPER, PIGTAIL HAMSTRING TENDON, 5MM
• 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: jared engle ; 8009337001
• MDR Report Key: 20455635
• Report Number: 1220246-2024-08137
• Device Sequence Number: 20986671
• Product Code: LXH
• UDI-Device Identifier: 00888867006911
• UDI-Public: (01)00888867006911(11)210603(10)47322120
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 08/15/2025

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, PIGTAIL HAMSTRING TENDON, 5MM
• Device Catalogue Number: AR-1278P
• Device Lot Number: 47322120
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2021
• 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