MAUDE Adverse Event Report: ARTHREX, INC. BUR,OVAL,CLEARCUT,8 FLUT,5.0MMX 13CM; BURR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	BUR,OVAL,CLEARCUT,8 FLUT,5.0MMX 13CM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2021
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 hood of the ar-8500coe broke off during use for a rcr with a distal clavicle excision and sub-acrominal decompression.The piece was retrieved from the patient; male, (b)(6) years old.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-8500coe oval burr was received for investigation (no finished good batch indicator present, but outer tube had batch 47682012 listed along its outer diameter).Visual inspection identified that the clear hood component had broken off of the distal end of the burr.The fragment generated during this event was not returned for review.Material analysis of the device indicated that the burr met all as-received specifications.As such, the observed condition is most likely the result of prying/leveraging the device against bone and/or hard tissue during use.

• Brand Name: BUR,OVAL,CLEARCUT,8 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: 11274345
• Report Number: 1220246-2021-02534
• Device Sequence Number: 19124334
• Product Code: GFF
• UDI-Device Identifier: 00888867043756
• UDI-Public: 00888867043756
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2021

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,CLEARCUT,8 FLUT,5.0MMX 13CM
• Device Catalogue Number: AR-8500COE
• Device Lot Number: 11441454
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/22/2021
• Supplement Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 02/12/2021
• 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