BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10.0 MM FLIP CUTTER II

    MDR report key: 3901520 · Received June 30, 2014

    Report

    Report Number
    1220246-2014-00108
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    January 22, 2014
    Report Date
    June 9, 2014
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. 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. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE IS RETURNED AND ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. DEVICE FACILITY WILL NOT RETURN DEVICE.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT DURING AN ACL RECONSTRUCTION, A FLIP CUTTER BROKE DURING INSERTION. THE TIP BROKE WHEN THE SURGEON WAS CUTTING ON THE FEMORAL SIDE. THE SURGEON EASILY RETRIEVED THE TIP AND A NEW DEVICE WAS USED TO FINISH THE CASE. NEW INFORMATION PROVIDED: THE ORIGINAL CASE WAS ABANDONED. IT WAS REPORTED THAT DURING THE PROCEDURE, THE DRILL WAS SPINNING BUT THE FLIP CUTTER WAS NOT. THE FLIPCUTTER COULD NOT BE ACTUATED TO REMOVE FROM THE JOINT. AN ATTEMPT TO MANUALLY FLIP THE BLADE WAS UNSUCCESSFUL. THE SURGEON DECIDED TO REAM FROM THE OUTSIDE IN. THE REAMER GUIDE PIN DID NOT FIT TIGHTLY IN THE FLIPCUTTER GUIDE HOLE BUT THEN PERSISTED TO REAM TO THE SHAFT OF THE FLIPCUTTER AT WHICH TIME, THE CUTTER WAS GRABBED WITH A GRASPER AND THE BLADE FLIPPED, SO IT COULD BE REMOVED THROUGH THE LATERAL TUNNEL. HE THEN USED THE REAMER TO COMPLETE THE TUNNEL, TRYING TO MAINTAIN THE ALIGNMENT AS BEST AS POSSIBLE. THE GRAFT WAS PREPARED IN THE USUAL MANNER BUT COULD NOT BE MADE TO TURN THE CORNER AT THE FEMORAL TUNNEL, DESPITE MULTIPLE ATTEMPTS. IT WAS NOTED THAT THE TUNNEL WAS NOT AS STRAIGHT AS USUAL. THERE WAS A CHANGE IN THE ANGLE AT THE DISTAL PART OF THE TUNNEL. DUE TO THE DELAY IN RETRIEVING THE BROKEN DEVICE THE TOTAL TOURNIQUET TIME EXCEEDED 2.5 HOURS (ANESTHESIA TIME WAS 3.5 HOURS) AND THE SURGERY WAS ABORTED. THE SURGEON PLANS TO OBTAIN IMAGING STUDIES AND PERFORM A REVISION OF THE FEMORAL TUNNEL TO ALLOW PASSAGE OF A GRAFT AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379039 10.0 MM FLIP CUTTER II INSTRUMENT, MANUAL, SURGICAL, GENERAL USE MDM ARTHREX, INC. 122031512

    Patients

    Seq Age Sex Outcome Treatment
    1 Other