MAUDE Adverse Event Report: ARTHREX, INC. SUTURE CUTTER, OPEN ENDED, LEFT NOTCH; MANUAL INSTR, GENERAL SURGICAL

Model Number	SUTURE CUTTER, OPEN ENDED, LEFT NOTCH
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that internal linkage that connects the handle to the jaw seems to be broken/disconnected.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The related condition is typically caused by applying excessive force while attempting to cut suture and/or an excessive amount of suture at one time.Fragments were accounted for and found during investigation/evaluation process.Shear pin is located inside the handle of the hand instrument.Unrelated, laser markings on the tip became discolored.

• Brand Name: SUTURE CUTTER, OPEN ENDED, LEFT NOTCH
• 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: 19133438
• Report Number: 1220246-2024-02119
• Device Sequence Number: 4658719
• Product Code: MDM
• UDI-Device Identifier: 00888867003590
• UDI-Public: 00888867003590
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/18/2024

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: SUTURE CUTTER, OPEN ENDED, LEFT NOTCH
• Device Catalogue Number: AR-11794L
• Device Lot Number: 82665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2017
• 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