MAUDE Adverse Event Report: ARTHREX, INC. 8.0 MM FLIP CUTTER II; MANUAL INSTR, GENERAL SURGICAL

Model Number	8.0 MM FLIP CUTTER II
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
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 anterior cruciate ligament surgery the tip of the flip cutter broke.No part of the device remained 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
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-1204af-80 batch 4290153549 was received for evaluation.Visual inspection revealed that the cutting blades were detached from the shaft's tip.A piece of the outer shaft's tip was also missing, and scratches were noted close to the shaft's tip.Functional testing was attempted by moving the inner and outer shafts; however, due to the damage, no movement was possible after pressing the button.The most likely causes of the reported failure are misaligned insertion, prying/leveraging the device, or the device making contact with another device during use.

• Brand Name: 8.0 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: 21918621
• Report Number: 1220246-2025-01775
• Device Sequence Number: 8907587
• Product Code: HWE
• UDI-Device Identifier: 00888867004245
• UDI-Public: (01)00888867004245(11)241101(17)291031(10)4290153549
• 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,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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: 8.0 MM FLIP CUTTER II
• Device Catalogue Number: AR-1204AF-80
• Device Lot Number: 4290153549
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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