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	Insufficient Information (4580)
Date of Event	06/24/2022
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 06/29/2022, it was reported by a sales representative via phone that on (b)(6) 2022 during a rotator cuff repair a ar-8500coe burrs clear portion on the tip came off into the patient.The fragment was retrieved, and the case was completed using a smaller burr.There was no patient effect reported.

• 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
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 15040485
• Report Number: 1220246-2022-05246
• Device Sequence Number: 14764642
• Product Code: GFF
• UDI-Device Identifier: 00888867043756
• UDI-Public: 00888867043756
• 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
• Report Date (Section B): 07/18/2022

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: 02/29/2024
• Device Model Number: BUR,OVAL,CLEARCUT,8 FLUT,5.0MMX 13CM
• Device Catalogue Number: AR-8500COE
• Device Lot Number: 10293463
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 07/18/2022
• Date Device Manufactured: 03/27/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown