MAUDE Adverse Event Report: ARTHREX, INC. BURR, ROUND, 8 FLUTE 4.0MM X 13CM; BURR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	BURR, ROUND, 8 FLUTE 4.0MM X 13CM
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/04/2019
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 during an elbow arthroscopy procedure, while the surgeon was using the ar-8400rbe, burr, he complained that the burr was producing metal shavings inside of the joint.Most of the shavings were able to be removed via suction but not all.Patient's bone quality was medium.No further details.
Additional Manufacturer Narrative
Complaint was confirmed.The returned round burr ar-8400rbe was visually inspected, showing damage to the shrink tubing at the proximal end of the inner tube.It was also noted that the inner tube at the distal end has a chip/nick right at the suction window, which had produced grooves cut into the id of outer tube.The most likely cause is excessive bending force or prying/leveraging the device during use.

• Brand Name: BURR, ROUND, 8 FLUTE 4.0MM 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: 8526672
• Report Number: 1220246-2019-01059
• Device Sequence Number: 1899858
• Product Code: GFF
• UDI-Device Identifier: 00888867043626
• UDI-Public: 00888867043626
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 06/19/2019

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: 05/31/2022
• Device Model Number: BURR, ROUND, 8 FLUTE 4.0MM X 13CM
• Device Catalogue Number: AR-8400RBE
• Device Lot Number: 10147149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2019
• Initial Date Received by Manufacturer: 04/05/2019
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 06/19/2019
• 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