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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2021
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 arthroscopic bone spur removal a small plastic piece fell out of the connection point at the back of the burr.The burr was used for the majority of the case (20-25mins) and then the round burr stopped rotating.It was further reported that no excessive leverage on the shaver hand piece was done.There was no harm for patient, operator or third party 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.
Additional Manufacturer Narrative
The complaint is confirmed based on the customer provided photo, which displays the broken piece of the burr.However, without return of the device for physical evaluation, the cause remains undetermined.No change in harm was identified.

• 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: 12466886
• Report Number: 1220246-2021-03625
• Device Sequence Number: 3787687
• Product Code: GFF
• UDI-Device Identifier: 00888867258754
• UDI-Public: 00888867258754
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 07/29/2022

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: 05/31/2025
• Device Model Number: BURR,ROUND,HL,RETRACT,8 FLUTE,5.5MMX18CM
• Device Catalogue Number: AR-6550RRBE
• Device Lot Number: 11199152
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown