MAUDE Adverse Event Report: ARTHREX, INC. BUR,OVAL,FLUSHCUT,12 FLUT, 5.5MMX 13CM; BURR,SURGICAL

Model Number	BUR,OVAL,FLUSHCUT,12 FLUT, 5.5MMX 13CM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
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 an hip surgery plastic debris came out of the two holes under the burr tip.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
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed based on the damage noted to the device.One unpackaged ar-8550fot oval, flushcut, 12 flute, 5.5 mm x 13 cm burr was received for investigation.The device was not able to be fully decontaminated and was evaluated via pictures.Visual evaluation of the attachments noted signs of use to the returned device.It was further noted that the shrink tubing was visible through holes under the burr tip and appeared to be damaged.Functional testing was not performed due to the biocontamination risk.The most likely cause for the reported failure can be attributed to a manufacturing issue with the assembly of the shrink tubing.Refer to investigation photos.

• Brand Name: BUR,OVAL,FLUSHCUT,12 FLUT, 5.5MMX 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: 21908563
• Report Number: 1220246-2025-01733
• Device Sequence Number: 11817674
• Product Code: GFF
• UDI-Device Identifier: 00888867044036
• UDI-Public: (01)00888867044036(11)240716(17)290630(10)15288265
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 07/30/2025

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: BUR,OVAL,FLUSHCUT,12 FLUT, 5.5MMX 13CM
• Device Catalogue Number: AR-8550FOT
• Device Lot Number: 15288265
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2024
• 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