MAUDE Adverse Event Report: ARTHREX, INC. BURR, OVAL, 8 FLUTE 5.0MM X 13CM; BURR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	BURR, OVAL, 8 FLUTE 5.0MM X 13CM
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/01/2020
Type of Reportable Event	Serious Injury
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 metal shavings were seen coming off the ar-8500obe burr during an acromioplasty.The rep reported that the procedure was completed without issue.Additional information received on 12/8/2020: the rep reported they assume the surgeon used suction on the shaver without running it to attempt to remove the metal shavings, but it cannot be confirmed if all shavings were removed from the patient.The surgeon sucked out as many as they could as best they could.

• Brand Name: BURR, OVAL, 8 FLUTE 5.0MM X 13CM
• Common Device Name: BURR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11075956
• Report Number: 1220246-2020-02434
• Device Sequence Number: 16945472
• Product Code: GFF
• UDI-Device Identifier: 00888867043862
• UDI-Public: 00888867043862
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: BURR, OVAL, 8 FLUTE 5.0MM X 13CM
• Device Catalogue Number: AR-8500OBE
• Device Lot Number: 11589062
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 12/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other