MAUDE Adverse Event Report: ARTHREX, INC. SUTURE CUTTER, 4.2 MM, STRAIGHT; MANUAL INSTR, GENERAL SURGICAL

Model Number	SUTURE CUTTER, 4.2 MM, STRAIGHT
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/22/2024
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
On 04/25/2024, it was reported by a sales representative via sems-06548841 that an ar-12250 suture cutters pin in the jaw of the cutter was sticking out and when the device was inspected further and attempted to push it back in, the pin fell out.The jaws of the cutter were no longer functional.This occurred during a shoulder scope.No additional information was provided, and additional information has been asked.
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 for the reported failure can be attributed to overstressing a device that is damaged naturally and inevitably as a result of normal wear or aging from repeated usage/reprocessing.Manufactured date: 01-aug-2017.

• Brand Name: SUTURE CUTTER, 4.2 MM, STRAIGHT
• 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: jared engle ; 8009337001
• MDR Report Key: 19378255
• Report Number: 1220246-2024-03687
• Device Sequence Number: 7703976
• Product Code: MDM
• UDI-Device Identifier: 00888867005655
• UDI-Public: 00888867005655
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 06/25/2025

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: SUTURE CUTTER, 4.2 MM, STRAIGHT
• Device Catalogue Number: AR-12250
• Device Lot Number: 82550
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2017
• 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