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	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device has not yet been evaluated.The root cause of the event could not be determined from the information available and without device evaluation.When the device evaluation becomes available, a follow-up report will be submitted.
Event or Problem Description
It was reported that during an asd-procedure small pieces of plastic fell off inside the patient.Same thing happened twice.Surgery was completed successfully with a new device with the same part number.The fragments remained inside the patient.It was not necessary to switch the surgical technique or do a second surgery.Update avoe 17-may-2024: further information was provided that the failure occurred with two devices during the same surgery.Plastic pieces were inside the patient but they were removed with the shaver.According to customer both burrs had loose plastic pieces coming out from the tip.
Additional Manufacturer Narrative
Complaint allegation was confirmed.One unpackaged sealed ar-8550obt, batch/serial number (b)(6), was received for evaluation.Visual inspection confirmed that there were no missing or broken pieces on the interior or exterior of the device.Evaluation of the customer's attached pictures revealed a piece of material; the plastic seems to be from a passport button cannula, which may indicate that the user shredded the passport button cannula with the burr.Functional testing with the testing console and the handpiece found not issues with the device.The reported failure is most likely due to user error, such as misaligned insertion, or from prying or levering the device against other instruments 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: 19508442
• Report Number: 1220246-2024-05516
• Device Sequence Number: 18002496
• Product Code: GFF
• UDI-Device Identifier: 00888867044050
• UDI-Public: 00888867044050
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2024

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, OVAL, 12 FLUTE 5.5MM X 13CM
• Device Catalogue Number: AR-8550OBT
• Device Lot Number: 15213853
• 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: 10/02/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/29/2024
• 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