BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL DRIVER SHAFT

    MDR report key: 3081110 · Received April 26, 2013

    Report

    Report Number
    0002249697-2013-01455
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6). AN EVENT REGARDING A FRACTURED TORX SCREWDRIVER TIP FROM A TRIDENT DRIVER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. IT IS NOT BELIEVED THE FAILURE WAS RELATED TO PATIENT FACTORS. THE EXACT ROOT CAUSE COULD NOT BE DETERMINED AS THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. IF THE DEVICE BECOMES AVAILABLE THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS DISCARDED IN O.R AND WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    WHILE IMPLANTING A STRYKER 6.5MM CANCELLOUS BONE SCREW, THE TIP OF THE SCREWDRIVER BROKE OFF. THE TIP WAS STUCK INSIDE THE HEAD OF THE SCREW BUT THE SCREW WAS DOWN. THE SURGEON DID NOT LIKE THE BACKUP SCREWDRIVER WE HAVE FOR THIS INDICATION, SO HE ELECTED TO USE A DEPUY SCREW AND SCREWDRIVER FOR THE 2ND SCREW.

    Description of Event or Problem · 1

    WHILE IMPLANTING A STRYKER 6.5MM CANCELLOUS BONE SCREW, THE TIP OF THE SCREWDRIVER BROKE OFF. THE TIP WAS STUCK INSIDE THE HEAD OF THE SCREW BUT THE SCREW WAS DOWN. THE SURGEON DID NOT LIKE THE BACKUP SCREWDRIVER WE HAVE FOR THIS INDICATION SO HE ELECTED TO USE A DEPUY SCREW AND SCREWDRIVER FOR THE 2ND SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183014 UNIVERSAL DRIVER SHAFT INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other