MAUDE Adverse Event Report: ARTHREX, INC. BURR, OVAL, 8 FLUTE 4.0MM X 13CM; BURR,SURGICAL

Model Number	BURR, OVAL, 8 FLUTE 4.0MM X 13CM
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
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 a shoulder decompression surgery the shaver handpiece ar-8332h (sn: (b)(6)) damaged 2 burrs ar-8400obe (batch 15446780).They got torn up in the bottom where they attach to shaver handpiece.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 the complaint allegation was confirmed.One unpackaged ar-8400obe batch 15446780 was received for evaluation.Visual inspection noted that the connector hub was broken off.A functional test cannot be performed as the hub was damaged.The most likely cause of the reported failure is a user error, specifically the incorrect setting of the device on the handpiece or the use of an incorrect handpiece.

• Brand Name: BURR, OVAL, 8 FLUTE 4.0MM 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: 23618781
• Report Number: 1220246-2025-05137
• Device Sequence Number: 9072624
• Product Code: GFF
• UDI-Device Identifier: 00888867043602
• UDI-Public: (01)00888867043602(11)250605(17)300531(10)15446780
• Combination Product (Y/N): N
• 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): 01/02/2026

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, 8 FLUTE 4.0MM X 13CM
• Device Catalogue Number: AR-8400OBE
• Device Lot Number: 15446780
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2025
• 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