MAUDE Adverse Event Report: ARTHREX, INC. BURR,ROUND,HL,RETRACT,8 FLUTE,5.0MMX18CM; BURR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	BURR,ROUND,HL,RETRACT,8 FLUTE,5.0MMX18CM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/24/2021
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 probable cause of the event could not be determined from the information available and without device evaluation.As no further investigation was able to be performed no change in harm was identified.This complaint will be included in trending per (b)(4).
Event or Problem Description
On (b)(6) 2021, it was reported by a distributor via sems that an ar-6500rrbe burr mechanism breaks and stops spinning.Surgeon thought it might be clogged but even after cleaning the burr, issue persisted.This was discovered during a procedure.When surgeon tried using a different burr, it broke as soon as it hit bone.This occurred again with a third burr from a different lot number.

• Brand Name: BURR,ROUND,HL,RETRACT,8 FLUTE,5.0MMX18CM
• 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: 13621256
• Report Number: 1220246-2022-04539
• Device Sequence Number: 5543207
• Product Code: GFF
• UDI-Device Identifier: 00888867258747
• UDI-Public: 00888867258747
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 02/28/2022

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: 11/30/2025
• Device Model Number: BURR,ROUND,HL,RETRACT,8 FLUTE,5.0MMX18CM
• Device Catalogue Number: AR-6500RRBE
• Device Lot Number: 12253040
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 02/28/2022
• Date Device Manufactured: 12/07/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown