MAUDE Adverse Event Report: ARTHREX, INC. BUR,RND,CLEARCUT 8 FLUT,4.0MMX 13CM; BURR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	BUR,RND,CLEARCUT 8 FLUT,4.0MMX 13CM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
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 the tip of the inner cylinder broke immediately after the first use.The number of rotations is 3600 in the forward rotation.The surgeon used a new product and the case is completed with no patient harm.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-8400cre clearcut burr (laser marked with sub-component batch 47681622) was received for investigation.It was determined that approximately 25.04mm of the distal tip had broken off of the inner tube.The outer tube was noted to be severely bent at the window, and upon removing the inner tube component from the outer tube, it was noted that the inner tube had also bent.Material analysis results identified that the tip met all as-received specifications.As such, the observed condition is consistent with user applied mechanical damage via prying/leveraging the burr against bone and/or hard tissue.

• Brand Name: BUR,RND,CLEARCUT 8 FLUT,4.0MMX 13CM
• Common Device Name: BURR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11302002
• Report Number: 1220246-2021-02560
• Device Sequence Number: 3737665
• Product Code: GFF
• UDI-Device Identifier: 00888867043510
• UDI-Public: 00888867043510
• 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): 05/03/2021

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: 11/30/2021
• Device Model Number: BUR,RND,CLEARCUT 8 FLUT,4.0MMX 13CM
• Device Catalogue Number: AR-8400CRE
• Device Lot Number: 10078117
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 02/09/2021
• Supplement Report FDA Received Date: 05/03/2021
• 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