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	02/03/2020
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 a micofracture, the burr, ar-8400rbe, produced metal shavings inside of the knee joint of the patient.The case was completed by using another manufacturers device.Additional information provided.Additional information provided 02/13/2020: it was reported that the surgeon could not confirm if all the metal shavings were removed from the patient.
Additional Manufacturer Narrative
Complaint confirmed.Visual inspection identified the presence of horizontal grooves worn into the distal, outer diameter of the ar-8400rbe inner tube.Corresponding grooves were identified within the inner diameter of the outer tube, and indicative of a site of metal debris production.Damage to the proximal end of the inner tube, just above the hub, was noted.This is indicative of prying/leveraging forces applied to the device during use, which can lead to metal debris production.Material analysis concluded that the ar-8400rbe met all as-received specifications.As such, this event is most likely the result of user applied mechanical forces through prying/leveraging the ar-8400rbe against bone and/or hard tissue 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: 9756707
• Report Number: 1220246-2020-01731
• Device Sequence Number: 14150037
• Product Code: GFF
• UDI-Device Identifier: 00888867043626
• UDI-Public: 00888867043626
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2020

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 Model Number: BURR, ROUND, 8 FLUTE 4.0MM X 13CM
• Device Catalogue Number: AR-8400RBE
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/13/2020
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 08/18/2020
• 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