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

Model Number	KINGFIR SUTR RETVR TISS GRSPR W/SR HNDL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 6/13/2024, an fda medwatch notification was received via email.A facility representative reported that an ar-13970sr kingfisher suture retriever/tissue grasper broke.All the broken fragments were removed.This was discovered during a shoulder arthroscopy procedure on (b)(6) 2024.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Additional information: g3, h3, h6 based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to excessive user-applied mechanical forces.

• Brand Name: KINGFIR SUTR RETVR TISS GRSPR W/SR HNDL
• 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: 19709739
• Report Number: 1220246-2024-06677
• Device Sequence Number: 12475404
• Product Code: NBH
• UDI-Device Identifier: 00888867015777
• UDI-Public: 00888867015777
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/06/2025

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 RETVR TISS GRSPR W/SR HNDL
• Device Catalogue Number: AR-13970SR
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided; 12/10/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 07/18/2024; 08/14/2024; 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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