MAUDE Adverse Event Report: ARTHREX, INC. 9.0 MM FLIP CUTTER II; MANUAL INSTR, GENERAL SURGICAL

Model Number	9.0 MM FLIP CUTTER II
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
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 an all-inside acl surgery the tip of the device broke after the tip was flipped.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: g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-1204af-90 serial/batch: (b)(6) was received for evaluation.Functional testing was not performed as the device was received broken.A visual evaluation found that the cutting blades were broken off, the inner and outer shaft tube tip were bent.The reported failure is most likely due to user error, improper bone preparation, and the use of excessive force.

• Brand Name: 9.0 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: 22337060
• Report Number: 1220246-2025-02663
• Device Sequence Number: 21086822
• Product Code: HWE
• UDI-Device Identifier: 00888867004269
• UDI-Public: (01)00888867004269(11)241101(17)291031(10)4284153405
• 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): 08/27/2025

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: 9.0 MM FLIP CUTTER II
• Device Catalogue Number: AR-1204AF-90
• Device Lot Number: 4284153405
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown