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

Model Number	STRIPPER SEMITENDINOSUS, 7MM
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/28/2023
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
On 12/26/2023, it was reported by a distributor via sems (b)(4) that an ar-1278l semitendinosus stripper would not cut.
Additional Manufacturer Narrative
Correction: b4, e1.Additional information: b5, d9, g3, h3, h6.Complaint is confirmed.Visual inspection identified the cutting sharp edge of the semitendinosus stripper, 7 mm had worn and nicks.Also, it shows depth scratches and chips on the surfaces of the shaft and handle.Laser marks were faded.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.Dfu-0023-eo warns against using dull devices.2.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.Dull devices may require replacement if they no longer perform as designed.Inspection prior to use should include verifying the cutting ability and sharpness of these points and edges.
Event or Problem Description
Additional information was provided on 01/15/2024, where it was stated that this event occurred during a knee surgery on (b)(6) 2023 where a replacement was used to complete the procedure.

• 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: 18547562
• Report Number: 1220246-2024-00411
• Device Sequence Number: 18432619
• Product Code: LXH
• UDI-Device Identifier: 00888867006904
• UDI-Public: 00888867006904
• Combination Product (Y/N): N
• Initial Reporter Country: DR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2024

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: 0086
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2023
• Supplement Date Received by Manufacturer: 01/15/2024
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 11/18/2024
• 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