BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREW, FULLY THREADED 5X40 MM

    MDR report key: 1884553 · Received October 21, 2010

    Report

    Report Number
    9610622-2010-00449
    Event Type
    Malfunction
    Date Received
    October 21, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 29, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K010801
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: REVIEW OF DEVICE HISTORY RECORD (DHR) - A REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS FOR THE LOCKING SCREW REVEALED NO DISCREPANCIES. DIMENSIONAL EXAMINATION - THE SCREW DIMENSIONS WERE FOUND INSIDE SPECIFICATIONS. FUNCTIONAL CHECK - COMPLAINED SCREW WAS TESTED WITH A SAMPLE PROXIMAL HUMERUS NAIL. THE REPORTED ISSUE WAS REPRODUCIBLE: IT WAS NOT POSSIBLE TO INSERT THE SCREW INTO THE THREADED PROXIMAL NAIL HOLES OF THE SAMPLE NAIL. AFTER THAT THE SCREW WAS VISUALLY INVESTIGATED. THE REPORTED ISSUE WAS REPRODUCIBLE. THE PER WAS ATTRIBUTED TO A PROCESS FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO OUR SALES REPRESENTATIVE THAT THE DEVICE DID NOT FIT INTO THE PROXIMATE WHOLES OF THE PHN NAIL. FURTHER IT WAS REPORTED THAT THE OPERATION WAS COMPLETED SUCCESSFUL AFTER USING A 5.5 MM SCREW WHICH FITS INTO THE NAIL. IN ADDITION HE CLAIMED THAT THE SURGERY HAD A DELAY OF 10 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING SCREW, FULLY THREADED 5X40 MM IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K120001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other