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

Model Number	BURR,ROUND,HL,RETRACT,8 FLUTE,5.5MMX18CM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On 05/15/2024 it was reported by a sales representative via sems-06568582 that an ar-6550rrbe burr end detached from the shaft inside the patient.This occurred during use in a case.The surgeon attempted to remove the end of the burr using a pituitary insulated long nose needle instrument.This attempt was unsuccessful.An additional larger incision was made in order to retrieve the fragment.The patient experienced no adverse effects other than the additional incision.The surgeon does not believe this incident is indicative of a product defect but rather attributes it to a judgment error.
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 user error of the device due to prying/leveraging the attachment during use.

• Brand Name: BURR,ROUND,HL,RETRACT,8 FLUTE,5.5MMX18CM
• 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: jared engle ; 8009337001
• MDR Report Key: 19503253
• Report Number: 1220246-2024-05463
• Device Sequence Number: 6812483
• Product Code: GFF
• UDI-Device Identifier: 00888867258754
• UDI-Public: 00888867258754
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BURR,ROUND,HL,RETRACT,8 FLUTE,5.5MMX18CM
• Device Catalogue Number: AR-6550RRBE
• Device Lot Number: 15191995
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown