MAUDE Adverse Event Report: ARTHREX INC. BURR, ROUND, HL, 8 FLUTE, 4.0MM X 19CM; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number	AR-6400RBE
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.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.Device history record review revealed nothing relevant to this event.The device was requested for evaluation but was not returned therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.Complainant's event typically caused by user mechanical damage to device such as hitting the device with another device or excessive bending forces being applied during use.The potential causes of this event are being 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 hip arthroscopy procedure, the surgeon noticed that the 40 mm round burr was splitting and producing metal shavings in the joint.A second burr of the same lot was opened and used and again, the burr split and produced metal shavings.The surgeon was able to remove most of the shavings via suction and the case was completed.

• Brand Name: BURR, ROUND, HL, 8 FLUTE, 4.0MM X 19CM
• Common Device Name: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7439301
• Report Number: 1220246-2018-00142
• Device Sequence Number: 1094588
• Product Code: GFF
• UDI-Device Identifier: 00888867039124
• UDI-Public: 00888867039124
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/18/2018

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: 01/01/2020
• Device Catalogue Number: AR-6400RBE
• Device Lot Number: 10027807
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2018
• Initial Report FDA Received Date: 04/18/2018
• 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