MAUDE Adverse Event Report: ARTHREX, INC. 8.5 MM FLIP CUTTER II; MANUAL INSTR, GENERAL SURGICAL

Model Number	8.5 MM FLIP CUTTER II
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
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 the all-inside anterior cruciate ligament surgery, the blade of the flipcutter could no longer be retracted.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: d9, g3, h3, h6.One unpackaged ar-1204af-85, flipcutter®, batch 5217171248, was received for investigation.Visual inspection revealed a fractured tip.Functional testing could not be performed due to the damage to the device.The most likely cause of the reported failure is off-axis insertion or prying and leveraging the device with excessive force.The complaint allegation is confirmed.Refer to the investigation photos.

• Brand Name: 8.5 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: 24470658
• Report Number: 1220246-2026-01067
• Device Sequence Number: 9581282
• Product Code: HWE
• UDI-Device Identifier: 00888867004252
• UDI-Public: (01)00888867004252(11)250801(17)300731(10)5217171248
• 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): 04/23/2026

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: 8.5 MM FLIP CUTTER II
• Device Catalogue Number: AR-1204AF-85
• Device Lot Number: 5217171248
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 01/29/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown