BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S4 SET SCREW NEW VERSION

    MDR report key: 3931442 · Received April 14, 2014

    Report

    Report Number
    3005673311-2014-00032
    Event Type
    Malfunction
    Date Received
    April 14, 2014
    Date of Event
    January 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    AESCULAP AG AND CO . KG
    Product Code
    KWP
    PMA / PMN Number
    K032219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL COMPONENTS RECEIVED FOR EVALUATION: SW774T LOT 51939275 AND SW774T LOT 51883070. THE SET SCREW AND TWO INSIDE THREADS OF THE POLYAXIAL SCREWS SW774T LOT 51883070 AND SW774 T LOT 51939275 WERE INSPECTED MICROSCOPICALLY. THE TREAD OF THE SET SCREW IS COMPLETELY PEELED OFF. FURTHERMORE THE INSIDE THREAD OF ONE POLYAXIAL SCREW (LOT 51939275) SHOWS VISIBLE DAMAGE ON BOTH SIDES. IN ADDITION THERE WERE IRREGULAR IMPRINTS FOUND ON THE BOTTOM OF THE SET SCREW. THESE MARKINGS ARE NOT TYPICAL FOR CORRECTLY TIGHTENED SET SCREWS. THE MOST LIKELY CAUSE FOR THIS ERROR PATTERN IS THAT THE SCREW WAS CROSS THREADED. THE SHEARING-OFF OF THE THREAD ON THE SET SCREW INDICATES THAT HIGH FORCES WERE EXERTED. THIS FAILURE APPEARS TO BE USER RELATED ERROR. THE MANUFACTURING DOCUMENTATION HAS BEEN CHECKED AND FOUND TO BE ACCORDING TO THE SPECIFICATION VALID AT THE TIME OF PRODUCTION.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT (B)(6). AT THE FINAL FIXATION OF THE SCREW, IT WAS UNABLE TO BE TURNED ANY FURTHER AT 10N TORQUE. THE SURGEON REMOVED THE SCREW AND FOUND THAT THE THREAD OF THE SCREW WAS PEELED OFF. OPERATION WAS DELAYED OVER 15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226640 S4 SET SCREW NEW VERSION BONE SCREW / SPINAL IMPLANT KWP AESCULAP AG AND CO . KG SW790T 51969913

    Patients

    Seq Age Sex Outcome Treatment
    1 Other