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

Model Number	BUR,OVAL,CLEARCUT,12 FLUT,5.5MMX 13CM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint confirmed.Even though the device was not returned for evaluation, picture provided by the customer showed the clear tip hood has melted.The cause of this event is undetermined; however, most likely caused by prying and/or leveraging the device for a prolonged use without proper irrigation.
Event or Problem Description
It was reported that during a surgery the sleeve around the tip of the device melted.No part of the device broke off.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint confirmed.Even thought the device was not returned for evaluation, picture provided by the customer showed the clear tip hood has melted.The cause of this event is undetermined; however, most likely caused by prying and/or leveraging the device for a prolonged use without proper irrigation.

• Brand Name: BUR,OVAL,CLEARCUT,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: 13333581
• Report Number: 1220246-2022-04316
• Device Sequence Number: 17486709
• Product Code: GFF
• UDI-Device Identifier: 00888867043961
• UDI-Public: 00888867043961
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2022

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: 09/30/2025
• Device Model Number: BUR,OVAL,CLEARCUT,12 FLUT,5.5MMX 13CM
• Device Catalogue Number: AR-8550COT
• Device Lot Number: 11982423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2022
• Supplement Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 03/07/2022
• Date Device Manufactured: 10/27/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown