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

Model Number	FIBERWIRE GRASPER W/ NR HANDLES
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During returned device evaluation, a reportable malfunction was discovered.Complaint confirmed.Visual evaluation confirms the upper jaw is broken.Device functioning was not performed due to the damaged of the device.The cause of this event is undetermined.
Event or Problem Description
On 12/07/2021, it was reported by a facility representative via sems that an ar-13975nr is not working properly.This was discovered during use in a procedure.No patient affect reported.There was no additional information provided.During returned device evaluation, a reportable malfunction was discovered.

• Brand Name: FIBERWIRE GRASPER W/ NR HANDLES
• 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: 13839506
• Report Number: 1220246-2022-04615
• Device Sequence Number: 12215509
• Product Code: NBH
• UDI-Device Identifier: 00888867015821
• UDI-Public: 00888867015821
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 03/21/2022

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: FIBERWIRE GRASPER W/ NR HANDLES
• Device Catalogue Number: AR-13975NR
• Device Lot Number: 32131
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 03/21/2022
• 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