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

Model Number	QUAD TENDON STRIPPER- CUTTER
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via sems-06062844 that an ar-2384 quad tendon stripper-cutter did not cut the tendon at all and was the first time it was used.This was discovered during an acl reconstruction procedure on (b)(6) 2023, with no reported patient harm.
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
Complaint is confirmed.Visual evaluation revealed that ar-2384 had damage on the edges around the stripper blade showing nicks.The dowel pins show signs of rust.Functional testing was not performed due to the damage to the stripper blade.The most likely cause for the reported failure can be attributed to user error of the device due to misaligned insertion.

• 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: 18104285
• Report Number: 1220246-2023-08657
• Device Sequence Number: 12690258
• Product Code: MDM
• UDI-Device Identifier: 00888867098244
• UDI-Public: 00888867098244
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2024

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: QUAD TENDON STRIPPER- CUTTER
• Device Catalogue Number: AR-2384
• Device Lot Number: 012239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2023
• Supplement Date Received by Manufacturer: 01/15/2024
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2022
• 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