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
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2021
Type of Reportable Event	Malfunction
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.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 or Problem 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.
Additional Manufacturer Narrative
This report is being submitted to provide additional information in h10.Additional investigation conclusion: the most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.

• Brand Name: KINGFIR SUTR RETRVR /TISS GRSPR W/WB
• 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: 19211890
• Report Number: 1220246-2024-02591
• Device Sequence Number: 18203122
• Product Code: NBH
• UDI-Device Identifier: 00888867015784
• UDI-Public: 00888867015784
• Combination Product (Y/N): N
• Initial Reporter Country: DR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2024

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown