BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREW VARIAX FULL THREAD 3.5MM / L10MM

    MDR report key: 4900155 · Received July 8, 2015

    Report

    Report Number
    0008031020-2015-00282
    Event Type
    Malfunction
    Date Received
    July 8, 2015
    Date of Event
    June 11, 2015
    Report Date
    February 28, 2017
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    HRS
    PMA / PMN Number
    K101056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ITEM WAS MISIDENTIFIED AT THE TIME THE COMPLAINT WAS OPENED. THE REPORTED EVENT OF LOCKING SCREW VARIAX FULL THREAD 3.5MM / L10MM. MISSING LASER MARKING FROM SCREW HEAD COULD NOT BE CONFIRMED. VISUAL INSPECTION ON THE RETURNED DEVICES SHOWS THAT THE DEVICE WAS RECEIVED COMPLETE AND INTACT. DIMENSIONAL INSPECTION ON THE RETURNED DEVICES SHOWS THE DEVICES MANUFACTURED PER SPECIFICATIONS. NO DEVIATION FROM THE DRAWING KE 1904500 WAS FOUND. FUNCTIONAL INSPECTION ON THE RETURNED DEVICES SHOWS THE DEVICE WERE PERFORMING AS EXPECTED. NO DEVICE FAILURE/ANOMALY WAS IDENTIFIED. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DURING CONTROL AND INSPECTION OF THE VARIAX KITS WITH THE CUSTOMER, SALES REP, OBSERVED THAT THERE WAS NO LOT NUMBER ON SOME OF THE LOCKING SCREWS.

    Description of Event or Problem · 1

    DURING CONTROL AND INSPECTION OF THE VARIAX KITS WITH THE CUSTOMER, SALES REP, OBSERVED THAT THERE WAS NO LOT NUMBER ON SOME OF THE LOCKING SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443957 LOCKING SCREW VARIAX FULL THREAD 3.5MM / L10MM PLATE, FIXATION, BONE HRS STRYKER LEIBINGER FREIBURG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other