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

Model Number	KINGFIR SUTR RETVR TISS GRSPR W/NR HNDL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, it was reported by a sales representative via (b)(4) that an ar-13970nr kingfisher suture retriever welds were broken and move in and out.There was no information of case involvement.Additional information was received on 7/19/2024: this occurred during use in an acl reconstruction procedure on (b)(6) 2024.A photo attachment shows the gap that is not supposed to be there and causes the tip to slide.The case was completed with another retriever ready and with no case delay reported.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is confirmed.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 of this failure is attributed to wear and tear damage incurred over repeated usage in the field.Manufactured date 2020.

• Brand Name: KINGFIR SUTR RETVR TISS GRSPR W/NR 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: 19961404
• Report Number: 1220246-2024-07138
• Device Sequence Number: 17908489
• Product Code: NBH
• UDI-Device Identifier: 00888867015760
• UDI-Public: 00888867015760
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2025

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/NR HNDL
• Device Catalogue Number: AR-13970NR
• Device Lot Number: 12091744
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 06/08/2025
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2020
• 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