MAUDE Adverse Event Report: ARTHREX, INC. BUR,OVAL,FLUSHCUT,12 FLUT,5.0MMX 13CM; BURR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	BUR,OVAL,FLUSHCUT,12 FLUT,5.0MMX 13CM
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/17/2022
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
It was reported on (b)(6) 2022 by a facility representative via sems that an ar-8500fot burr bent and twisted.This occurred during a case and broke in the joint space.Per facility: burr was being used in the posterior tibia.The surgeon experienced shavings from the burr.The guard on the burr bent and twisted around.The effect on the patient was metal shavers in the knee joint due to the guard bending and twisting.".
Additional Manufacturer Narrative
Complaint confirmed.Upon visual evaluation, no problem was noted with the (b)(4) packaged devices.The (b)(4) unpackaged devices were found to have the guard twisted and bent and on one device the burr came apart from the device.It was also noted that there was discoloration on the (b)(4) unpackaged devices.Based on the observed condition of the device, this event is most likely the result of user applied forces via prying/leveraging against bone and/or hard tissue during use.

• Brand Name: BUR,OVAL,FLUSHCUT,12 FLUT,5.0MMX 13CM
• Common Device Name: BURR, SURGICAL, GENERAL & PLASTIC SURGERY
• 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: 13995224
• Report Number: 1220246-2022-04699
• Device Sequence Number: 17442099
• Product Code: GFF
• UDI-Device Identifier: 00888867043848
• UDI-Public: 00888867043848
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/26/2022

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 Expiration Date: 06/30/2026
• Device Model Number: BUR,OVAL,FLUSHCUT,12 FLUT,5.0MMX 13CM
• Device Catalogue Number: AR-8500FOT
• Device Lot Number: 13735771
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2022
• Supplement Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 04/04/2022
• Supplement Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown