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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that there was a material breakage with the device.There was no harm for patient, operator or third party.There was no case involvement reported.No further information received.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged, ar-1278p, batch 10118081, tendon stripper, was received for evaluation.Visual inspection noted that the cutting edge is broken.Additionally, the laser marks on the handle are showing signs of metal surface oxidation.Functional testing was not performed due to the damage of the device.The most likely cause is attributed to wear and tear due to repeated use of the device.

• 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: 19643074
• Report Number: 1220246-2024-06518
• Device Sequence Number: 21001066
• Product Code: LXH
• UDI-Device Identifier: 00888867006911
• UDI-Public: 00888867006911
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 09/25/2024

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, PIGTAIL HAMSTRING TENDON, 5MM
• Device Catalogue Number: AR-1278P
• Device Lot Number: 10118081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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