MAUDE Adverse Event Report: ARTHREX, INC. 9.5 MM FLIP CUTTER II; MANUAL INSTR, GENERAL SURGICAL

Model Number	9.5 MM FLIP CUTTER II
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an anterior cruciate ligament repair the device malfunctioned and jammed in the knee during use.It was further reported that the flipcutter broke and the outer tube came away from the inner tube leaving the inner tube in the bone.It was further reported that the device became twisted in the process.The broken piece was safely removed out of the patient and no harm was caused.The surgery was finished successfully with a new device with a different 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.

• Brand Name: 9.5 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: 23309847
• Report Number: 1220246-2025-04636
• Device Sequence Number: 17353055
• Product Code: HWE
• UDI-Device Identifier: 00888867004276
• UDI-Public: (01)00888867004276(11)240601(17)290531(10)4155141849
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/16/2025

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: 9.5 MM FLIP CUTTER II
• Device Catalogue Number: AR-1204AF-95
• Device Lot Number: 4155141849
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2024
• 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