MAUDE Adverse Event Report: ARTHREX, INC. BUR,OVAL,FLUSHCUT,12 FLUT, 5.5MMX 13CM; BURR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	BUR,OVAL,FLUSHCUT,12 FLUT, 5.5MMX 13CM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/06/2021
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2021, it was reported by a sales representative via sems that ar-8550fot bur,oval,flushcut,12 flut, 5.5mmx 13cm broke off inside the patient.All broken fragments were removed using this was discovered during use in a procedure on.The case was completed.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation identified that the inner tube had the distal end broken off, at the weld.Also, the outer tube had circumferential grooves present along the inner diameter at the hood.The cause of this event is undetermined; however, probable causes include prying/leveraging the device during use and/or interference between the device and bone/hard tissue.

• Brand Name: BUR,OVAL,FLUSHCUT,12 FLUT, 5.5MMX 13CM
• Common Device Name: BURR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 12364382
• Report Number: 1220246-2021-03565
• Device Sequence Number: 19716929
• Product Code: GFF
• UDI-Device Identifier: 00888867044036
• UDI-Public: 00888867044036
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Model Number: BUR,OVAL,FLUSHCUT,12 FLUT, 5.5MMX 13CM
• Device Catalogue Number: AR-8550FOT
• Device Lot Number: 12451939
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2021
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown