BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREW VARIAX FULL THREAD 3.5MM / L18MM

    MDR report key: 4900186 · Received July 8, 2015

    Report

    Report Number
    0008031020-2015-00283
    Event Type
    Malfunction
    Date Received
    July 8, 2015
    Date of Event
    June 11, 2015
    Report Date
    March 1, 2017
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    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 / L18MM , DEVICE NOT ENGRAVED, 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 DEVICE MANUFACTURED PER SPECIFICATIONS. NO DEVIATION FROM THE DRAWING KE 1904500 WAS FOUND. THE DEVICE IS NOT SUPPOSED TO BE ENGRAVED. 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.

    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
    444162 LOCKING SCREW VARIAX FULL THREAD 3.5MM / L18MM PLATE, FIXATION, BONE HRS STRYKER LEIBINGER FREIBURG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other