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

Model Number	FIBERWIRE GRASPER W/ SR HANDLE
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021, it was reported by a sales representative via sems that an ar-13975sr fiberwire grasper, distal end broke. this was discovered during use in procedure on (b)(6) 2021. all fragment were removed from the patient.
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
Complaint confirmed, the upper jaw was found to be broken.The actuating mechanism appears to function as intended.The cause of the broke jaw is undetermined, however a likely cause is user-applied mechanical forces.

• 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: vik bajnath ; 8009337001
• MDR Report Key: 12819165
• Report Number: 1220246-2021-03944
• Device Sequence Number: 19280836
• 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): 12/21/2021

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: 77662
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2021
• Supplement Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown