MAUDE Adverse Event Report: ARTHREX, INC. KINGFIR SUTR RETVR TISS GRSPR W/SR HNDL; ACCESSORIES, ARTHROSCOPIC

Model Number	KINGFIR SUTR RETVR TISS GRSPR W/SR HNDL
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2022
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 06/22/2022 it was reported by a distributor via sems that the clamp tip on the ar-13970sr kingfisher suture retriever, is broken.This was discovered during an unspecified procedure on (b)(6) 2022.Requested additional information.
Additional Manufacturer Narrative
Complaint confirmed.Upon visual inspection, it was noted that the upper moving jaw was broken off.The broken piece was not returned for investigation.The cause of this remains undetermined, however a probable cause can be attributed to prying/leveraging forces.

• Brand Name: KINGFIR SUTR RETVR TISS GRSPR W/SR HNDL
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• 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: vik bajnath ; 8009337001
• MDR Report Key: 14978208
• Report Number: 1220246-2022-05223
• Device Sequence Number: 5690434
• Product Code: NBH
• UDI-Device Identifier: 00888867015777
• UDI-Public: 00888867015777
• 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,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2022

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
• Device Lot Number: 35744
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 08/31/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown