BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROCHANTERIC NAIL KIT, TI GAMMA3 Ø11X200MM X 130°

    MDR report key: 3013709 · Received March 20, 2013

    Report

    Report Number
    0009610622-2013-00141
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 25, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) OF THE REPORTED NAIL KIT REVEALED NO DEVIATION. A PHYSICAL EVALUATION OF THE AFFECTED PACKAGING COULD NOT BE PERFORMED AS THE PACKAGING IN QUESTION WAS NOT RETURNED TO FOR INVESTIGATION; ACCORDING TO INFORMATION RECEIVED IT WAS DISCARDED. SINCE 2004 A NEW SET SCREW PACKAGING FOR THE GAMMA3 NAIL KIT BLISTER HAD ALREADY BEEN ESTABLISHED. THE SIZE AND THE OUTER BOX AS WELL AS THE BLISTER IN THE BOX ARE KEPT UNCHANGED. IMPROVEMENT: THE SEPARATE SMALL WHITE FOAM IN THE STERILE GAMMA3 NAIL KIT NOW IS PROVIDED WITH AN APERTURE, SO THAT THE SET SCREW IS VISIBLE THROUGH THE (UNOPENED) BLISTER AS WELL AS FROM THE BOTTOM SIDE AFTER REMOVING THE TYVEK LID. THE REFERENCE NUMBER HAS NOT BEEN CHANGED. SINCE (B)(4) 2004 THE NAIL KITS ARE SHIPPED WITH THE DESCRIBED CHANGED PACKAGING. THE REPORTED EVENT COULD NOT BE CONFIRMED AS THE PACKAGING WAS DISCARDED AND AS THE LOT CODE IS UNKNOWN, A MORE PRECISE STATEMENT CAN NOT BE GIVEN AND THE EXACT ROOT CAUSE OF THE REPORTED EVENT CAN NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THEY OPENED THE PACKAGING AND OBSERVED THAT THE SET SCREW WAS MISSING. THERE WAS A DELAY OF 5 MINS. A REPLACEMENT WAS AVAILABLE AND HAS BEEN IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THEY OPENED THE PACKAGING AND OBSERVED THAT THE SET SCREW WAS MISSING. THERE WAS A DELAY OF 5 MINS. A REPLACEMENT WAS AVAILABLE AND HAS BEEN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115960 TROCHANTERIC NAIL KIT, TI GAMMA3 Ø11X200MM X 130° IMPLANT HSB STRYKER OSTEOSYNTHESIS-KIEL K156246

    Patients

    Seq Age Sex Outcome Treatment
    1 Other