MAUDE Adverse Event Report: ARTHREX, INC. BURR, OVAL, 12 FLUTE 5.5MM X 13CM; BURR,SURGICAL

Model Number	BURR, OVAL, 12 FLUTE 5.5MM X 13CM
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during a surgery when in use, the device was noisy, deflects and was out of alignment.Per complaint reporter there was no harm for patient, operator or third party.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
Complaint allegation is confirmed.One unpackaged, ar-8550obt, burr, oval, 12 flute, 5.5 mm x 13 cm, batch/serial number (b)(6), was received for evaluation.Upon visual evaluation, it was noted that the spring retainer was bent, which is likely related to the allegation.Functional tests with an ar-8330f serial (b)(6) were performed and the inner tube rotates freely inside the outer tube.The most likely cause for the reported failure can be attributed to user error of the devices due to side-loading the devices during use.

• Brand Name: BURR, OVAL, 12 FLUTE 5.5MM X 13CM
• 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: 21026862
• Report Number: 1220246-2024-09075
• Device Sequence Number: 18405127
• Product Code: GFF
• UDI-Device Identifier: 00888867044050
• UDI-Public: (01)00888867044050(11)240417(17)290331(10)15235995
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 02/28/2025

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, OVAL, 12 FLUTE 5.5MM X 13CM
• Device Catalogue Number: AR-8550OBT
• Device Lot Number: 15235995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 02/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2024
• 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
• Patient Sex: Unknown