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); Superficial (First Degree) Burn (2685)
Date of Event	03/01/2022
Type of Reportable Event	Serious Injury
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)2022, it was reported by a sales representative via sems that an ar-8500obe burr burn the patient superficially when it was connected to an ar-8330h shaver handpiece.This was discovered during a procedure on (b)(6)2022.
Additional Manufacturer Narrative
The complaint is unable to be confirmed.One unpackaged ar-8500obe was returned for investigation.Visual evaluation concluded without the observance of any signs of heat damage across the returned oval burr.Attempts at functional testing revealed that the inner tube was locked within the outer tube, and would not allow the cutting head to rotate.The spring retainer was bent out of position, indicating that the device had been subjected to prying/leveraging forces during use.
Additional Manufacturer Narrative
Additional info: b5.Complaint confirmed.Functional testing was performed using burr ar-8500obe, batch 14339092 (reference case-2022-00102166-1).When the device was operated in forward and reverse, the burr would lock up and cause a c34 overload error to appear on the shaver console.The burr lockup (blade not able to rotate) can be attributed to the burr damage, as noted in (b)(4) (bent hub causes the inner tube to hit the outer tube during use).The damage to the burr is likely caused by device sideloading (reference dfu-0215-7 rev 0, section f, item 7).Excessive loading is also known to decrease irrigation flow which would in turn, cause overheating (reference dfu-0215-7 rev 0, section f, item 10), although no excessive heat was observed from the burr or shaver handpiece during testing.
Event or Problem Description
Additional information received 3/2/2022: this was discovered during an arthroscopic rcr procedure on 2/22/2022.Case was completed without further issues using another shaver and burr.A dualwave inflow/outflow tubing were used during the case and there was no interruption of the in and outflow.There was an alarm that when off and the patient's burn occurred within 30 seconds.

• 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: 13839537
• Report Number: 1220246-2022-04617
• Device Sequence Number: 1308495
• Product Code: GFF
• UDI-Device Identifier: 00888867043862
• UDI-Public: 00888867043862
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,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: 09/30/2026
• Device Model Number: BURR, OVAL, 8 FLUTE 5.0MM X 13CM
• Device Catalogue Number: AR-8500OBE
• Device Lot Number: 14339092
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2022
• Supplement Date Received by Manufacturer: 03/01/2022; 03/01/2022
• Initial Report FDA Received Date: 03/21/2022
• Supplement Report FDA Received Date: 04/11/2022; 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2021
• 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