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 Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
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 during a surgery that the shaver blade broke when the surgeon attempted to remove it.The broken pieces were retrieved from the patient.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: b5, h3, h6.
Event or Problem Description
*** 04-november-2025 majung - further information was received from arthrex fr: it was reported during a surgery that the shaver blade unclipped.The surgeon noticed the anomaly before the shaver blade entered the joint.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device of the same part number.It was not necessary to switch the surgical technique or perform a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-8550obt, burr, batch 15019599, was received for investigation.Visual inspection noted surface damage to the outer hood and inner tube.The inner tube was also detached from the blue hub, likely due to excessive forces during use.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error due to prying or leveraging the attachment during use.The complaint allegation that the blade has disengaged from the handpiece is confirmed.Refer to the attached investigation photos.

• 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: 23322194
• Report Number: 1220246-2025-04662
• Device Sequence Number: 9938074
• Product Code: GFF
• UDI-Device Identifier: 00888867044050
• UDI-Public: (01)00888867044050(11)221103(17)271031(10)15019599
• 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,Followup
• Report Date (Section B): 12/30/2025

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: BURR, OVAL, 12 FLUTE 5.5MM X 13CM
• Device Catalogue Number: AR-8550OBT
• Device Lot Number: 15019599
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Supplement Date Received by Manufacturer: Not provided; 12/18/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 11/21/2025; 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2022
• 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