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

Model Number SUTURE CUTTER, OPEN ENDED, LEFT NOTCH

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 01/25/2021

Event Type  malfunction  

Event Description

It was reported that internal linkage that connects the handle to the jaw seems to be broken/disconnected.

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
• Type of Device: 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
• MDR Text Key: 340852705
• Report Number: 1220246-2024-02119
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 00888867003590
• UDI-Public: 00888867003590
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 01/25/2021
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1