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 Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation confirmed that the outer tube hood of the ar-8500fos had been bent around the cutting head.Chipping was observed along the outer diameter of the hood, at the interface between the hood and the cutting head, consistent with a site of metal debris production.Material analysis confirmed that the device met all as-received specifications.This event is most likely caused by the application of user applied mechanical forces via prying/leveraging against bone or hard tissue.
Event or Problem Description
It was reported that during a procedure, the rotating portion of the oval burr, ar-8500fos, made contact with the hood and torqued the hood around the fluted burr.This happened twice in this case with two of the same burrs from different lot numbers.No adverse effect to the patient.Additional information provided 9/3/2019: procedure was an rotator cuff repair.Bone quality was decent, but not great.The burrs produced debris and tiny metal particles were left in joint.

• 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: 9118574
• Report Number: 1220246-2019-01326
• Device Sequence Number: 2763538
• Product Code: GFF
• UDI-Device Identifier: 00888867043831
• UDI-Public: 00888867043831
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/25/2019

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 Expiration Date: 03/31/2024
• Device Model Number: BUR,OVAL,FLUSHCUT,6 FLUT,5.MMX 13CM
• Device Catalogue Number: AR-8500FOS
• Device Lot Number: 10297122
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 09/25/2019
• 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