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	Insufficient Information (4580)
Date of Event	11/18/2021
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 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) 2021, it was reported by an arthrex employee via sems that an ar-8400cre burr was damaged at the cutting edge.This was discovered use in a foot joint repair procedure when the shaver was used on cartilage/tissue on (b)(6) 2021.The case was completed using a new product.Rep contacted (b)(6) to confirm whether fragments were produced/entered patient.Update: rep returned contact (b)(6).Confirmed fragments were produced and entered the patient.All debris was confirmed removed.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation showed that approx.1 inch of the distal tip had broken off of the inner tube.The outer tube was noted to have scratches at the transparent hood.Device functioning could not be performed due to the damaged of the device.The cause is undetermined; however, a most likely cause is user applied mechanical damage via prying/leveraging the burr against bone and/or hard tissue.

• 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: 12984010
• Report Number: 1220246-2021-04090
• Device Sequence Number: 4432034
• 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): 01/07/2022

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: 02/28/2026
• Device Model Number: BUR,RND,CLEARCUT 8 FLUT,4.0MMX 13CM
• Device Catalogue Number: AR-8400CRE
• Device Lot Number: 12922386
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2021
• Supplement Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown