MAUDE Adverse Event Report: ARTHREX, INC. KINGFIR SUTR RETRVR /TISS GRSPR W/WB; MANUAL INSTR, GENERAL SURGICAL

Model Number KINGFIR SUTR RETRVR /TISS GRSPR W/WB

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/26/2021

Event Type  malfunction  

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.Complaint confirmed.One unpackaged ar-13970w, batch 5613977 was received for investigation.Visual inspection identified that the jaws at the distal tip were hanging loose from the assembly, as the tip pin had broke.The observed condition is consistent with misuse, such as through the use of excessive force when handling the device.

Event Description

It was reported that during a meniscus arthroscopy performed on (b)(6) 2021, the gripper was discovered to be broken at the top where it holds objects.The procedure was completed using a new product of the same part number with no patient effect.

• Brand Name: KINGFIR SUTR RETRVR /TISS GRSPR W/WB
• 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: 19211890
• MDR Text Key: 341609809
• Report Number: 1220246-2024-02591
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00888867015784
• UDI-Public: 00888867015784
• Combination Product (y/n): N
• Reporter Country Code: DR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KINGFIR SUTR RETRVR /TISS GRSPR W/WB
• Device Catalogue Number: AR-13970W
• Device Lot Number: 5613977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Date Manufacturer Received: 08/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1