MAUDE Adverse Event Report: ARTHREX, INC. BUR,OVAL,SJ,10 FLUT,3.0MMX 7CM; BURR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	BUR,OVAL,SJ,10 FLUT,3.0MMX 7CM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2022
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 (b)(6) 2022 it was reported by a distributor via sems that an ar-7300obt oval burr broke 1cm from the top, the broke fragment was retrieved.This was discovered during an unspecified procedure, with no patient harm reported.On (b)(6) 2022 it was reported by a distributor via sems that an ar-7300obt oval burr broke 1cm from the top inside the patient¿s ankle during use, the broke fragment was retrieved.This was discovered during use in an ankle procedure on (b)(6) 2022.

• Brand Name: BUR,OVAL,SJ,10 FLUT,3.0MMX 7CM
• 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: 14976417
• Report Number: 1220246-2022-05199
• Device Sequence Number: 5073535
• Product Code: GFF
• UDI-Device Identifier: 00888867041950
• UDI-Public: 00888867041950
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/11/2022

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: 03/31/2024
• Device Model Number: BUR,OVAL,SJ,10 FLUT,3.0MMX 7CM
• Device Catalogue Number: AR-7300OBT
• Device Lot Number: 10297476
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2022
• Initial Report FDA Received Date: 07/11/2022
• Date Device Manufactured: 04/05/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown