BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKELETAL DYNAMICS

    MDR report key: 10299817 · Received July 20, 2020

    Report

    Report Number
    3006742481-2019-00002
    Event Type
    Malfunction
    Date Received
    July 20, 2020
    Date of Event
    June 25, 2019
    Report Date
    October 9, 2019
    Manufacturer
    SKELETAL DYNAMICS
    Product Code
    HWC
    UDI-DI
    00841506101286
    PMA / PMN Number
    K182492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIVING THE FDA REPORT (MW5089046), A CALL WAS MADE TO THE REPRESENTATIVE TO GET MORE INFORMATION FORM THE COMPLAINT. THE INFORMATION PROVIDED WAS THAT THE SURGEON WAS HAVING ISSUES WITH THE VARIABLE ANGLE DRIVER TIP DURING FINAL TORQUEING. WE WERE UNABLE TO GET MORE INFORMATION REGARDING THIS EVENT VIA THE REPRESENTATIVE. THE INSTRUMENT WAS NOT RETURNED TO BE INVESTIGATED. THE INFORMATION PROVIDED IS INSUFFICIENT TO CONCLUDE A CAUSATION OF WHAT ACTUALLY HAPPENED. TESTING WAS PERFORMED ON A SIMILAR DRIVER MODEL IN STOCK AND WAS SEEN TO BE WITHIN SPEC OF THE ALLOTTED TORQUE LIMITS.

    Description of Event or Problem · 1

    USER SUBMITTED A REPORT TO THE FDA STATING: WHILE PLATING A VARIABLE ANGLE SCREW, THE TIP OF THE DRIVER COLD WELDED IN THE HEAD OF THE SCREW AND BROKE OFF. DECISION WAS MADE TO LEAVE THE TIP OF THE DRIVER IN THE SCREW HEAD, AS SCREW HAD GOOD PLACEMENT AND TIP WAS COLD WELDED WITHOUT POSSIBILITY OF MIGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763958 SKELETAL DYNAMICS DRIVER, AO CONNECTION, POLYAXIAL LOCKING SCREW HWC SKELETAL DYNAMICS Driver, AO Connection, Polyaxial Locking Screw 00841506101286

    Patients

    Seq Age Sex Outcome Treatment
    1 Other