MAUDE Adverse Event Report: ARTHREX, INC. BURR, OVAL, 8 FLUTE 5.0MM X 13CM; BURR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	BURR, OVAL, 8 FLUTE 5.0MM X 13CM
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Codes	Burn(s) (1757); Insufficient Information (4580)
Date of Event	10/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021 it was reported by a sales representative via (b)(6) that during a shoulder decompression procedure an ar-8330h started to decrease speed and then created smoke while burning the patients skin.The shaver and burr were replaced to complete the case.
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.
Additional Manufacturer Narrative
The complaint is confirmed.The reported device was not returned for investigation.Pictures were not provided for evaluation.However, the available information notes that the rotation of the device faced resistance and slowed down, indicating a potential collision between the burr tip and the hood.This type of damage is an indication of force applied to the hood of the device during use, characterizing misuse.Per dfu-0215-7 rev.1, "forcing the hood of any burrs, including flushcut burrs and clearcut burrs into anatomically tight spaces can cause the burr tip to collide with the hood and render the device inoperable." in addition, the mention of smoke indicates the device was utilized without adequate irrigation, since smoke would not be be visible in a fluid environment.The lack of irrigation further corroborates misuse as the probable root cause, and may have contributed to overheating.

• Brand Name: BURR, OVAL, 8 FLUTE 5.0MM X 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: 12853673
• Report Number: 1220246-2021-03983
• Device Sequence Number: 17295294
• Product Code: GFF
• UDI-Device Identifier: 00888867043862
• UDI-Public: 00888867043862
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 06/07/2023

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 Expiration Date: 04/30/2026
• Device Model Number: BURR, OVAL, 8 FLUTE 5.0MM X 13CM
• Device Catalogue Number: AR-8500OBE
• Device Lot Number: 13294619
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2021
• Supplement Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 06/07/2023
• Date Device Manufactured: 05/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown