MAUDE Adverse Event Report: ARTHREX, INC. BONE CUTTER, 4.0MM X 13CM; SAW BLADE

Model Number	BONE CUTTER, 4.0MM X 13CM
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
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
On 8-dec-2025, it was reported by a sales representative via (b)(4) that an ar-8400bc bone cutter is sticking at the mouth and not oscillating.Noticed during a case, swapped, and case completed with no patient effect.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is a user error, including side-loading, excessive force, and/or insufficient irrigation.Directions for use dfu-0215-eo revision 1 - disposable arthroscopic shaver blades, burrs, powerpick, powerasp, nanoresection, and shaverdrill devices.F.Precautions 7.Excessive "side-loading" on the device during use does not improve cutting performance and in extreme cases will cause irreversible damage to the device.9.Irreversible damage to all devices will result if they are run without the flow of irrigation (dry).The complaint allegation was not confirmed.No evidence of that failure was received.

• Brand Name: BONE CUTTER, 4.0MM X 13CM
• Common Device Name: SAW BLADE
• 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: 23906488
• Report Number: 1220246-2025-05852
• Device Sequence Number: 9194807
• Product Code: GFA
• UDI-Device Identifier: 00888867043466
• UDI-Public: (01)00888867043466(11)250924(17)300831(10)15503076
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2026

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: BONE CUTTER, 4.0MM X 13CM
• Device Catalogue Number: AR-8400BC
• Device Lot Number: 15503076
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 12/08/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown