MAUDE Adverse Event Report: ARTHREX, INC. 11.0 MM FLIP CUTTER II; MANUAL INSTR, GENERAL SURGICAL

Model Number	11.0 MM FLIP CUTTER II
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a knee surgery the flipcutter broke into two pieces when encountering a hard bone.The surgeon removed all fragments 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
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.One unpackaged ar-1204af-110 flip cutter (batch 2269125445) was received for investigation.Visual inspection noted that the tip was fractured.Functional testing was not performed due to the damage to the device.The most likely cause of the reported failure can be attributed to user-related mechanical overstress, such as prying or leveraging the device with excessive force.The complaint allegation is confirmed.Refer to the investigation photos.

• Brand Name: 11.0 MM FLIP CUTTER II
• Common Device Name: MANUAL INSTR, GENERAL 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: 24092303
• Report Number: 1220246-2026-00233
• Device Sequence Number: 10259062
• Product Code: HWE
• UDI-Device Identifier: 00888867004139
• UDI-Public: (01)00888867004139(11)221001(17)270930(10)2269125445
• 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
• Report Date (Section B): 04/10/2026

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: 11.0 MM FLIP CUTTER II
• Device Catalogue Number: AR-1204AF-110
• Device Lot Number: 2269125445
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2025
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2022
• 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