MAUDE Adverse Event Report: ARTHREX, INC. BUR,RND,CLEARCUT 8 FLUT,4.0MMX 13CM; BURR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	BUR,RND,CLEARCUT 8 FLUT,4.0MMX 13CM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2023
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 01/23/2023 by a arthrex employee via sems that an ar-8400cre burr broke off in the joint case involvement, device broke during use.While shaving an osteophyte during ope of an ankle joint, it broke off from the tip.All debris was removed.Used another companies' product and the case is completed.
Additional Manufacturer Narrative
Complaint confirmed.Upon visual evaluation, it was noted that the tip of the inner tube had broken off at the weld.Cause is undetermined.

• Brand Name: BUR,RND,CLEARCUT 8 FLUT,4.0MMX 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: 16323666
• Report Number: 1220246-2023-06246
• Device Sequence Number: 12760657
• Product Code: GFF
• UDI-Device Identifier: 00888867043510
• UDI-Public: 00888867043510
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2023

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,RND,CLEARCUT 8 FLUT,4.0MMX 13CM
• Device Catalogue Number: AR-8400CRE
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2023
• Supplement Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown