MAUDE Adverse Event Report: ARTHREX, INC. BURR,ROUND,HL,RETRACT,8 FLUTE,5.5MMX18CM; BURR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	BURR,ROUND,HL,RETRACT,8 FLUTE,5.5MMX18CM
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
It was reported that during a hip arthroscopy the burr broke off at the attachment.The broken piece was retrieved from patient.No harm for patient, operator or third party was reported.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.Update 22-nov-2021: the shaft broke off and therefore it was easy to remove it from patient.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-6550rrbe was received for investigation.Visual inspection identified that the ar-6550rrbe had broken apart at the c0883-01 spring retailer.This is most likely as a result of prying/leveraging the device within the handpiece, or the result of an attempt to remove the device from the handpiece.

• Brand Name: BURR,ROUND,HL,RETRACT,8 FLUTE,5.5MMX18CM
• 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: 12953823
• Report Number: 1220246-2021-04061
• Device Sequence Number: 19930981
• Product Code: GFF
• UDI-Device Identifier: 00888867258754
• UDI-Public: 00888867258754
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 12/14/2021

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: 01/31/2026
• Device Model Number: BURR,ROUND,HL,RETRACT,8 FLUTE,5.5MMX18CM
• Device Catalogue Number: AR-6550RRBE
• Device Lot Number: 12791034
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown