BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREW ANCHORAGE Ø3.5MM / L16MM

    MDR report key: 3770549 · Received April 24, 2014

    Report

    Report Number
    0008031020-2014-00203
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    HRS
    PMA / PMN Number
    K083447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE WAS DISCARDED BY THE HOSPITAL.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IT WAS IDENTIFIED DURING PREVIOUS CASES THAT THE SCREW IS CONCOMITANT FOR THIS REPORTED FAILURE (SCREW WENT THROUGH THE PLATE). IF ANY OTHER INFORMATION IS PROVIDED INDICATING OTHERWISE, THE INVESTIGATION WILL BE REWORKED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ELECTIVE, INDEX LAPIDUS SURGERY, THE 3.0 LOCKING SCREW DID NOT LOCK IN, WENT THROUGH THE PLATE HOLE STRAIGHT THROUGH TO THE BONE. THE SURGEON THEN USED A 3.5 LOCKING SCREW IN THE SAME HOLE SUCCESSFULLY. THEN WITH A DIFFERENT PLATE HOLE THE SURGEON PROCEEDED DIRECTLY TO A 3.5 LOCKING SCREW AND THE SURGEON COMMENTED THAT ALTHOUGH IT WAS SEATED, HE FELT IF HE KEPT TORQUING THE SCREWDRIVER, THE SCREW WOULD HAVE ALSO GONE THROUGH THE PLATE HOLE. THE 3.5 LOCKING SCREWS REMAINED IMPLANTED. THE 3.0 LOCKING SCREW THAT WAS REMOVED HAS BEEN DISCARDED BY THE HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ELECTIVE, INDEX LAPIDUS SURGERY, THE 3.0 LOCKING SCREW DID NOT LOCK IN, WENT THROUGH THE PLATE HOLE STRAIGHT THROUGH TO THE BONE. THE SURGEON THEN USED A 3.5 LOCKING SCREW IN THE SAME HOLE SUCCESSFULLY. THEN WITH A DIFFERENT PLATE HOLE THE SURGEON PROCEEDED DIRECTLY TO A 3.5 LOCKING SCREW AND THE SURGEON COMMENTED THAT ALTHOUGH IT WAS SEATED, HE FELT IF HE KEPT TORQUING THE SCREWDRIVER, THE SCREW WOULD HAVE ALSO GONE THROUGH THE PLATE HOLE. THE 3.5 LOCKING SCREWS REMAINED IMPLANTED. THE 3.0 LOCKING SCREW THAT WAS REMOVED HAS BEEN DISCARDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250015 LOCKING SCREW ANCHORAGE Ø3.5MM / L16MM PLATE, FIXATION, BONE HRS STRYKER TRAUMA SELZACH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other