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	09/26/2018
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 requested/is expected but has not returned for evaluation.The 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 scope procedure, the surgeon completed the acromioplasty by using the ar-8500fos, oval flushcut burr without any issue.The surgeon then went to burr the distal clavicle.As the surgeon placed the burr between the acromion and clavicle and activated the burr, the back of the sheath twisted and metal debris shot out of the device.The surgeon communicated to the rep that nothing felt or seemed abnormal with the burr during use.The surgeon was able to retrieve some of the metal shavings from the patient by using another manufacturer's shaver.The rep confirmed that not all of the shavings were fully retrieved from inside the patient.The case was completed by using another manufacturer's burr.The rep stated it is unknown how the device became twisted.The rep reported that the surgeon did not deviate from the proper surgical technique.The rep confirmed that the device will be returning for evaluation.

• 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: 7947408
• Report Number: 1220246-2018-00703
• Device Sequence Number: 1500076
• Product Code: GFF
• UDI-Device Identifier: 00888867043831
• UDI-Public: 00888867043831
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 10/09/2018

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: 03/31/2023
• Device Model Number: BUR,OVAL,FLUSHCUT,6 FLUT,5.MMX 13CM
• Device Catalogue Number: AR-8500FOS
• Device Lot Number: 10204895
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 10/09/2018
• 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