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

Catalog Number	AR-8500FOE
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The returned device met all material specifications as received.The evaluation revealed a frozen burr caused by hood to flute collision.Device history record review revealed nothing relevant to this event.Hood to flute collisions are typically caused when end user applied excessive force on the back of the hood causing it to make contact with the burr flute.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a rotator cuff repair with subacromial decompression with acromioplasty procedure, the surgeon started the oval flush cut 8 flute burr, ar-8500foe, on forward at 8000 rpms.Without much force, the burr contacted the bone and the flute twisted and bent around the burr causing metal shavings to come off from the device and fall into the patient's joint.The surgeon removed as much of the metal shavings as he could using a shaver and suction but, there were still some minuscule remnants remaining.Another oval flush cut 8 flute burr of the same lot was opened and used to complete the case.

• Brand Name: BUR, OVAL, FLUSHCUT, 8 FLUTE, 5.0MM X 13 CM
• Common Device Name: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6411474
• Report Number: 1220246-2017-00074
• Device Sequence Number: 736945
• Product Code: GFF
• UDI-Device Identifier: 10888867043821
• UDI-Public: 10888867043821
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/16/2017

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: 08/01/2021
• Device Catalogue Number: AR-8500FOE
• Device Lot Number: 10064385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2017
• Initial Report FDA Received Date: 03/16/2017
• 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
• Patient Age: 54 YR
• Patient Weight: 69