MAUDE Adverse Event Report: ARTHREX, INC. BONE CUTTER,5.0MM X 13CM; SAW BLADE

Model Number	BONE CUTTER,5.0MM X 13CM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopic shoulder surgery the inner part of the bone cutter broke.The device did not break inside 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
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation is confirmed.One unpackaged ar-8500bc serial/batch number (b)(6) was received for investigation.Functional testing was not performed due to the damage to the device.Visual inspection noted that the device is noticeably used and broken in half.The most likely cause is attributed to misuse/user error due to excessive force being used.Per the directions for use (dfu) dfu-0215-eo revision 1, disposable arthroscopic shaver blades, burrs, powerpick¿, powerasp¿, nanoresection¿ and shaverdrill¿ devices: "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.".

• Brand Name: BONE CUTTER,5.0MM 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: 24036468
• Report Number: 1220246-2026-00137
• Device Sequence Number: 10482514
• Product Code: GFA
• UDI-Device Identifier: 00888867043732
• UDI-Public: (01)00888867043732(11)240605(17)290531(10)15259120
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 03/13/2026

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,5.0MM X 13CM
• Device Catalogue Number: AR-8500BC
• Device Lot Number: 15259120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 12/19/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown