MAUDE Adverse Event Report: ARTHREX, INC. BURR, ROUND, 8 FLUTE 5.0MM X 13VM; BURR,SURGICAL

Model Number	BURR, ROUND, 8 FLUTE 5.0MM X 13VM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via sems that an ar-8500rbe burr, round, 8 flute 5.0mm x had an issue.After a few minutes of using the device, the surgeon noticed it was not working properly.The surgeon took the device out of the patient and then off the handpiece and saw that the bottom plastic had broken off and had fallen out of the handpiece.The burr was then disposed of, and another burr was opened to complete the case without harming the patient.This was discovered during an unspecified procedure on (b)(6) 2023, with no patient harm.Additional information received on (b)(6) 2023: this was discovered during a subacromial decompression on (b)(6) 2023.The case was delayed for no longer than 60 seconds and all fragments were retrieved.
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
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to a manufacturing issue.Ncr-24360 has been open to address this issue.

• Brand Name: BURR, ROUND, 8 FLUTE 5.0MM X 13VM
• Common Device Name: BURR,SURGICAL
• 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: emily shafer ; 8009337001
• MDR Report Key: 17555934
• Report Number: 1220246-2023-07510
• Device Sequence Number: 19742801
• Product Code: GFF
• UDI-Device Identifier: 00888867043879
• UDI-Public: 00888867043879
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 12/30/2024

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: BURR, ROUND, 8 FLUTE 5.0MM X 13VM
• Device Catalogue Number: AR-8500RBE
• Device Lot Number: 15046356
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2023
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown