MAUDE Adverse Event Report: ARTHREX, INC. FLIPCUTTER II, SHORT 10.5MM; MANUAL INSTR, GENERAL SURGICAL

Model Number	FLIPCUTTER II, SHORT 10.5MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
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 reconstruction surgery the flipcutter broke.All fragments were retrieved 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
Additional information: d9, g3, h3, h6.The complaint allegation is confirmed.One unpackaged, ar-1204as-105, flipcutter¿ ii, short 10.5 mm, was received for investigation.Visual evaluation of the returned device noted that the device had disassembled.Additionally, the distal tip of the shaft was damaged.Functional testing was performed by pressing the button in and sliding the driver end forward and back.The cutting tip was not engaging in any modes.The most likely cause for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces and/or prying/leveraging the device during use.

• Brand Name: FLIPCUTTER II, SHORT 10.5MM
• 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: 21026573
• Report Number: 1220246-2024-09073
• Device Sequence Number: 9022792
• Product Code: HWE
• UDI-Device Identifier: 00888867004290
• UDI-Public: (01)00888867004290(11)230201(17)280131(10)3026128631
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 03/04/2025

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: FLIPCUTTER II, SHORT 10.5MM
• Device Catalogue Number: AR-1204AS-105
• Device Lot Number: 3026128631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• 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