MAUDE Adverse Event Report: ARTHREX, INC. ROUND BURR, HL, 8 FLUTE 5.0MM X 19CM; BURR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	ROUND BURR, HL, 8 FLUTE 5.0MM X 19CM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, it was reported by a sales representative via sems that an ar-6500rbe round burr had an issue, the hip burr had the clear shroud fell off during a case.The surgeon was able to retrieve the shroud and complete the case.This was discovered during use with no impact to the patient.
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.
Additional Manufacturer Narrative
The complaint is confirmed based on the customer-provided photo, which displays a fragment of what appears to be the shrink tubing for the ar-6500rbe.However, as the device was not returned for physical evaluation, the cause remains undetermined.No change in harm was identified.

• Brand Name: ROUND BURR, HL, 8 FLUTE 5.0MM X 19CM
• 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: 14337040
• Report Number: 1220246-2022-04879
• Device Sequence Number: 20035646
• Product Code: GFF
• UDI-Device Identifier: 00888867039452
• UDI-Public: 00888867039452
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2022

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 Model Number: ROUND BURR, HL, 8 FLUTE 5.0MM X 19CM
• Device Catalogue Number: AR-6500RBE
• Device Lot Number: 14919224
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2022
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 05/20/2022
• Date Device Manufactured: 01/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown