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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a knee surgery there was a problem with the stripper.When taking the half-tensioned sample, the stripper cut the tendo too soon.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Update avor 07-oct-2024.The surgeon stated that there was no particular explanation, because he did everything as usual.The error occurred on two occasions and (b)(4) was opened for the second occasion.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.Upon visual inspection, it was noted that the distal end of the sharp edge of the pigtail hamstring tendon stripper, open end, 5 mm had chipped.Functional testing was not performed due to the damage to the device.The most likely cause of this failure is attributed to wear and tear damage incurred over repeated usage.

• 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: 20224604
• Report Number: 1220246-2024-07646
• Device Sequence Number: 12617186
• Product Code: LXH
• UDI-Device Identifier: 00888867006911
• UDI-Public: 00888867006911
• 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,Followup
• Report Date (Section B): 02/03/2025

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2024
• Supplement Date Received by Manufacturer: 10/07/2024; 01/07/2025
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 10/16/2024; 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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