BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U-BLADE SET, TI GAMMA3® Ø10.5X85MM

    MDR report key: 4180695 · Received October 17, 2014

    Report

    Report Number
    0009610622-2014-00560
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K043431-LTF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS NOT CONFIRMED AND A PHYSICAL EXAMINATION WAS NOT POSSIBLE AS THE U-BLADE SET WAS NOT RETURNED FOR EVALUATION (STILL IMPLANTED). REVIEW OF THE DHR FOR THE SUBJECT PRODUCT REVEALED NO DISCREPANCIES. THE ITEM REPORTED WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. HOWEVER, REFERRING TO THE EVENT DESCRIPTION IT CAN BE ASSUMED THAT THE SURGEON DID NOT PRECISELY FOLLOW THE STEPS OF THE GAMMA3 U-BLADE LAG SCREW INSERTION AS INSTRUCTED IN THE GAMMA3 U-BLADE LAG SCREW OPERATIVE TECHNIQUE. NEVERTHELESS, BASED ON THE ABOVE OBSERVATIONS AND ON THE INFORMATION GIVEN, THE EXACT ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. NO NON-CONFORMITY WAS IDENTIFIED. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED. ADDITIONAL INFORMATION WAS REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DURING SURGERY THE SURGEON PLACED THE U-LAG SCREW. THE SURGEON TRIED TO INSERT THE U-BLADE USING THE INSERTER. HOWEVER, THE SURGEON WAS NOT ABLE TO INSERT THE U-BLADE. THE SURGEON FINISHED THE SURGERY WITHOUT INSERTING THE U-BLADE. AFTER SURGERY, WHEN SALES REP ASKED SURGEON, IT TURNED OUT THAT DIRECTION OF U-LAG SCREW WAS INCORRECT. THEREFORE, IT IS THOUGHT THAT THE SET SCREW WAS PLACED IN THE SLOT OF U-BLADE OF LAG SCREW. THE SURGEON IS MONITORING THE PATIENT.

    Description of Event or Problem · 1

    DURING SURGERY THE SURGEON PLACED THE U-LAG SCREW. THE SURGEON TRIED TO INSERT THE U-BLADE USING THE INSERTER. HOWEVER, THE SURGEON WAS NOT ABLE TO INSERT THE U-BLADE. THE SURGEON FINISHED THE SURGERY WITHOUT INSERTING THE U-BLADE. AFTER SURGERY, WHEN SALES REP ASKED SURGEON, IT TURNED OUT THAT DIRECTION OF U-LAG SCREW WAS INCORRECT. THEREFORE, IT IS THOUGHT THAT THE SET SCREW WAS PLACED IN THE SLOT OF U-BLADE OF LAG SCREW. THE SURGEON IS MONITORING THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662724 U-BLADE SET, TI GAMMA3® Ø10.5X85MM IMPLANT HSB STRYKER TRAUMA KIEL K05D102

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other