MAUDE Adverse Event Report: ARTHREX, INC. BUR,OVAL,FLUSHCUT,6 FLUT,5.MMX 13CM; BURR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	BUR,OVAL,FLUSHCUT,6 FLUT,5.MMX 13CM
Health Effect - Clinical Codes	Failure of Implant (1924); Foreign Body In Patient (2687)
Date of Event	03/16/2021
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.
Event or Problem Description
It was reported that during a shoulder surgery the milling guard became bent inside the shoulder and metal debris was produced inside the shoulder.The splinters could be partially removed from the surgeon.The surgery was finished successfully with the same device anyway.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-8500fos flushcut burrs was returned for investigation.Visual inspection identified that the outer tube hood at the distal end of the burr had warped around the cutting head.The observed condition of the devices is consistent with prying/leveraging of the burrs against bone and/or hard tissue, resulting in interference between the outer tube hood and the cutting tip.

• Brand Name: BUR,OVAL,FLUSHCUT,6 FLUT,5.MMX 13CM
• Common Device Name: BURR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11629787
• Report Number: 1220246-2021-02847
• Device Sequence Number: 14207151
• Product Code: GFF
• UDI-Device Identifier: 00888867043831
• UDI-Public: 00888867043831
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2021

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 Expiration Date: 11/30/2024
• Device Model Number: BUR,OVAL,FLUSHCUT,6 FLUT,5.MMX 13CM
• Device Catalogue Number: AR-8500FOS
• Device Lot Number: 10516941
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 08/02/2021
• Patient Sequence Number: 1