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	Insufficient Information (4580)
Date of Event	01/16/2024
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 02/16/2024, it was reported by a distributor via (b)(4) that an ar-13970w suture retrievers clamp broke.This occurred during a case.No additional information was provided, and additional information has been asked.
Event or Problem Description
Additional information was provided on (b)(6) 2024, stating that this event occurred during a meniscus arthroscopy procedure on (b)(6) 2024.The device broke while in use, and all fragments were retrieved.Another clamp was used to complete the procedure.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-13970w suture retriever lot number: 11818633 was received for evaluation.Visual inspection noted that the jaw of the device would not completely close.Functional testing was performed with a test sheet and it was observed that the ar-13970w suture retriever would not grasp.The most likely cause can be attributed to misuse/mishandling due to the damage to the device.Refer to investigation photos.

• 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: 18829999
• Report Number: 1220246-2024-01274
• Device Sequence Number: 7720954
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2024

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: KINGFIR SUTR RETRVR /TISS GRSPR W/WB
• Device Catalogue Number: AR-13970W
• Device Lot Number: 11818633
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2024
• Supplement Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2020
• 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