BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW LOCKING

    MDR report key: 2943737 · Received February 5, 2013

    Report

    Report Number
    2520274-2013-00780
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Report Date
    January 10, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ONE SCREW HEAD WAS PROVIDED WITH THE SUBTASK ASSOCIATED WITH THIS COMPLAINT. IT HAS BEEN CONSIDERABLY DAMAGED. NO PART NOR LOT NUMBERS WERE PROVIDED. IT IS APPARENTLY FROM ONE OF THE VARIABLE ANGLE FAMILY OF SCREWS, PROBABLY 2.4MM OR 2.7MM. BECAUSE THE HEADS OF BOTH SCREW FAMILIES ARE NEARLY IDENTICAL, IT IS NOT POSSIBLE TO ACCURATELY DETERMINE TO WHICH SCREW FAMILY THIS HEAD MAY HAVE BELONGED. THE DRIVE HAS MODERATE DAMAGE, PRIMARILY TO THE UPPER THIRD OF THE DRIVE. THERE IS DISPLACED MATERIAL ON THE ID OF THE STARDRIVE LOBES. THE TOP OF THE HEAD HAS LIGHT TO MODERATE DAMAGE, CONCENTRATED IN THE DRIVE AREA. THE HEAD THREADS HAVE SUSTAINED MODERATE TO HEAVY DAMAGE, PRIMARILY IN THE FORM OF COMPRESSION OF THE MAJOR DIAMETER DOWNWARDS INTO THE MINOR DIAMETER. THERE ARE TWO IMPACT, COMPRESSION MARKS MADE SUBSEQUENT TO THE DAMAGE SUSTAINED BY THE MAJOR DIAMETER. THESE MARKS ARE APPROXIMATELY DIAMETRICALLY OPPOSED. BOTH THREADS END AT APPROXIMATELY THE NECK WITH THE THREAD HAVING BEEN SEPARATED FROM THE BASIS MATERIAL, I.E.: THE THREADS HAVE BEEN TURNED INTO WIRES AND ARE HANGING FREELY. DUE TO THE TYPE AND EXTENT OF DAMAGE INCURRED, AND ALSO BECAUSE NO PART NOR LOT NUMBERS WERE PROVIDED, A FINITE EVALUATION WAS NOT POSSIBLE.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: DURING TALUS NAVICULAR FUSION PROCEDURE ONE SCREW HEAD BROKE OFF; THE SCREW SHAFT REMAINS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48018 SCREW LOCKING HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1