BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLIPCUTTER II, SHORT, 9 MM

    MDR report key: 6562833 · Received May 12, 2017

    Report

    Report Number
    1220246-2017-00194
    Event Type
    Injury
    Date Received
    May 12, 2017
    Date of Event
    April 14, 2017
    Report Date
    May 12, 2017
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    UDI-DI
    00888867004436
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE EVALUATION REVEALED THE WELD BETWEEN THE ACTUATOR AND ADAPTER TUBE HAS FAILED AND INDENTATIONS/CIRCULAR MARKS ARE PRESENT ON THE CUTTER TIP END. COMPLAINANT'S EVENT TYPICALLY CAUSED BY USER MECHANICAL DAMAGE TO DEVICE SUCH AS HITTING THE DEVICE WITH ANOTHER DEVICE, PRYING/LEVERAGING OR EXCESSIVE BENDING FORCES BEING APPLIED DURING USE. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THIS IS THE SECOND COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ALLOGRAFT ACL PROCEDURE, DURING THE FEMORAL SOCKET PREPARATION, THE SURGEON WAS ATTEMPTING TO DRILL THROUGH THE PATIENT'S FEMUR WITH A 8.5 MM SHORT FLIPCUTTER (LOT: 703270942, LINE 191033). THE INNER CANNULATION OF THE 8.5 MM FLIPCUTTER BROKE AND SEPARATED FROM THE OUTER SLEEVE AND DID NOT ALLOW THE BLADE TO RE-FLIP. THE SURGEON USED A HEMOSTAT TO FLIP THE BLADE MANUALLY AND WAS ABLE TO FINISH THE DRILLING. THEN, WHILE THE SURGEON WAS PREPARING THE TIBIAL SOCKET, HE WAS USING A 9 MM SHORT FLIPCUTTER (LOT: 701370384, LINE 191034). DURING THIS PROCESS, THE 9 MM FLIPCUTTER WOULD NOT FLIP AFTER RETRO DRILLING. THE INNER PART OF THE 9 MM FLIPCUTTER BROKE AND SEPARATED FROM THE OUTER SLEEVE. THE SURGEON HAD TO CHUCK THE OUTER SLEEVE OF THE 9 MM FLIPCUTTER AND MAKE A FULL TUNNEL VS. HIS ORIGINAL PLAN OF A SOCKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344788 FLIPCUTTER II, SHORT, 9 MM INSTRUMENT, MANUAL, SURGICAL, GENERAL USE MDM ARTHREX, INC. 701370384 00888867004436

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other