MAUDE Adverse Event Report: ARTHREX, INC. BUR,OVAL,FLUSHCUT,12 FLUT,5.0MMX 13CM; BURR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	BUR,OVAL,FLUSHCUT,12 FLUT,5.0MMX 13CM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2021
Type of Reportable Event	Malfunction
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 arthroscopic surgery the device had metal abrasion.The surgeon was able to wash out all the fragments and finished the surgery successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-8500fot (laser marked with component batch 47682032) for further details.Visual inspection identified that the outer tube hood was bent around the cutting head.Inspection under micro-vu id:654 identified metal abrasion along the ar-8500fot cutting head and along the warped edge of the outer tube hood, consistent with sites of metal debris production.Based on the observed condition of the device, this event is most likely the result of user applied forces via prying/leveraging against bone and/or hard tissue during use.

• Brand Name: BUR,OVAL,FLUSHCUT,12 FLUT,5.0MMX 13CM
• Common Device Name: BURR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11545029
• Report Number: 1220246-2021-02763
• Device Sequence Number: 4108406
• Product Code: GFF
• UDI-Device Identifier: 00888867043848
• UDI-Public: 00888867043848
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 06/25/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Model Number: BUR,OVAL,FLUSHCUT,12 FLUT,5.0MMX 13CM
• Device Catalogue Number: AR-8500FOT
• Device Lot Number: 11441638
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 06/25/2021
• Patient Sequence Number: 1