MAUDE Adverse Event Report: ARTHREX, INC. BUR,OVAL,FLUSHCUT,RETR,8 FLUT,5.0MMX13C; BURR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	BUR,OVAL,FLUSHCUT,RETR,8 FLUT,5.0MMX13C
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/11/2022
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
It was reported on 08/11/2022 by a sales representative via sems that an ar-8500rfoe burr broke off the shaft.This was discovered during a case and broke inside the joint space.
Additional Manufacturer Narrative
Complaint is confirmed.One unpackaged ar-8500rfoe retractable flushcut burr, oval, 8 flute, 5.0 mm x 13 cm serial/batch number (b)(6) was received for investigation.The intent of the functional test fails when the inner tube doesn't fit inside the outer tub because of the damage in the shrink tubing.Visual evaluation found that the inner tube broke off at the tip.No fragments were returned for investigation.The cause remains undetermined.

• Brand Name: BUR,OVAL,FLUSHCUT,RETR,8 FLUT,5.0MMX13C
• 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: 15310747
• Report Number: 1220246-2022-05421
• Device Sequence Number: 14140165
• Product Code: GFF
• UDI-Device Identifier: 00888867259782
• UDI-Public: 00888867259782
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 02/15/2023

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 Model Number: BUR,OVAL,FLUSHCUT,RETR,8 FLUT,5.0MMX13C
• Device Catalogue Number: AR-8500RFOE
• Device Lot Number: 14932785
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2022
• Supplement Date Received by Manufacturer: 08/11/2022
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown