MAUDE Adverse Event Report: ARTHREX, INC. FIBERWIRE GRASPER W/ SR HANDLE; ACCESSORIES, ARTHROSCOPIC

Model Number	FIBERWIRE GRASPER W/ SR HANDLE
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, it was reported by a sales representative via sems that a ar-13975sr fiberwire® grasper w/sr handle is broken at the distal end of the tip.This occurred during a case, no pieces were left in the patient, and the case was completed.There was no patient effect reported.
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.
Additional Manufacturer Narrative
Since the complaint device was not returned, a physical evaluation of the device was not performed.However, without the device being returned or any photos provided, the report event is not confirmed.Based on the device damage that was reported, the most likely cause for the reported failure can be attributed to misuse/mishandling.
Event or Problem Description
Additional information was provided on 12/16/2022 where it was reported that this event occurred on (b)(6) 2022 during an alc repair.The device bent while removing the hardware.Another grasper was used to complete the case.

• Brand Name: FIBERWIRE GRASPER W/ SR HANDLE
• 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: jared engle ; 8009337001
• MDR Report Key: 16051575
• Report Number: 1220246-2022-05980
• Device Sequence Number: 6346916
• Product Code: NBH
• UDI-Device Identifier: 00888867015838
• UDI-Public: 00888867015838
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 06/14/2024

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: FIBERWIRE GRASPER W/ SR HANDLE
• Device Catalogue Number: AR-13975SR
• Device Lot Number: 14999540
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2022
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 12/27/2022
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/07/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown