MAUDE Adverse Event Report: ARTHREX, INC. QUAD TENDON STRIPPER- CUTTER; MANUAL INSTR, GENERAL SURGICAL

Model Number	QUAD TENDON STRIPPER- CUTTER
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 24th october 2023, it was reported by a sales representative via email that an ar-2384, quad tendon stripper-cutter, had difficulties opening all the way and was very stiff.It was able to be pried open by forcing the handgrip, however it was deemed inappropriate to continue to use the product.This was discovered when the consigned instrumentation was opened during a regular quadriceps acl procedure on (b)(6).The procedure was completed successfully.
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.
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(s) of the reported failure is the instrument's wear and tear from repetitive use and reprocessing.The complaint allegation was confirmed based on the customer's attached picture that show the device with nicks on the cutting edges evidence of the device wear and tear.

• Brand Name: QUAD TENDON STRIPPER- CUTTER
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 18150816
• Report Number: 1220246-2023-08770
• Device Sequence Number: 14880218
• Product Code: MDM
• UDI-Device Identifier: 00888867098244
• UDI-Public: 00888867098244
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 02/06/2025

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: QUAD TENDON STRIPPER- CUTTER
• Device Catalogue Number: AR-2384
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2023
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown