MAUDE Adverse Event Report: ARTHREX, INC. BUR,OVAL,CLEARCUT,12 FLUT,5.0MMX 13CM; BURR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	BUR,OVAL,CLEARCUT,12 FLUT,5.0MMX 13CM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/19/2022
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 that during a sas surgery the plastic protective cap of the burr broke off inside the patient.It was further reported that the cap could not be retrieved and an additional surgery is needed to retrieve the broken device out of the patient.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
The complaint could not be confirmed based on the customer provided photo.The photo is not clear to determined if anything broke.No change in harm was identified.

• Brand Name: BUR,OVAL,CLEARCUT,12 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: 13471865
• Report Number: 1220246-2022-04424
• Device Sequence Number: 1791014
• Product Code: GFF
• UDI-Device Identifier: 00888867043770
• UDI-Public: 00888867043770
• Combination Product (Y/N): N
• Initial Reporter Country: LS
• 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): 05/02/2022

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: 08/31/2025
• Device Model Number: BUR,OVAL,CLEARCUT,12 FLUT,5.0MMX 13CM
• Device Catalogue Number: AR-8500COT
• Device Lot Number: 11725031
• 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: 01/21/2022
• Supplement Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 05/04/2022
• Date Device Manufactured: 09/18/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown