BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAG SCREW, TI GAMMA3 Ø10.5X95MM

    MDR report key: 3132233 · Received May 29, 2013

    Report

    Report Number
    0009610622-2013-00293
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    March 29, 2013
    Report Date
    March 29, 2013
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K032244
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING DOCUMENTS. THE LAG SCREW WAS DOCUMENTED CONFORMED TO SPECIFICATIONS PRIOR TO DISTRIBUTION. DURING THE DIMENSIONAL EVALUATION ALL RELEVANT MEASUREMENTS OF THE LAG SCREW WERE VERIFIED TO BE WITHIN SPECIFICATION PARAMETERS. THOUGH THERE WERE NO DAMAGES VISIBLE ON THE LAG SCREW AT FIRST SIGHT, UNDER STEREO-MICROSCOPE IT IS CLEARLY VISIBLE THAT THE FIRST TWO WINDINGS OF THE INNER THREAD ARE SIGNIFICANTLY DEFORMED. FUNCTIONALITY IS NOT GIVEN ANY LONGER AS IT IS NOT POSSIBLE TO ASSEMBLE THE LAG SCREW TO A LAG SCREWDRIVER DUE TO THE DAMAGED THREAD. DURING SURGERY THE LAG SCREW MAY HAVE BEEN SCREWED ONTO THE LAG SCREWDRIVER UNDER MISALIGNMENT. THE OPERATIVE TECHNIQUE EXPLICITLY INSTRUCTS: ¿ENSURE THAT THE PINS OF THE LAG SCREWDRIVER ARE IN THE SLOTS OF THE LAG SCREW.¿ FOLLOWING THIS INSTRUCTION A MISALIGNMENT COULD NOT HAPPEN UNLESS THE LAG SCREWDRIVER IS DAMAGED. THUS, THE FOUND DAMAGE IS CLASSIFIED TO BE USER RELATED DUE TO DEVIATION FROM SURGICAL TECHNIQUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRIMARY SURGERY THE SURGEON HAD A PROBLEM WITH THE LAG SCREW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRIMARY SURGERY THE SURGEON HAD A PROBLEM WITH THE LAG SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235930 LAG SCREW, TI GAMMA3 Ø10.5X95MM IMPLANT HSB STRYKER TRAUMA KIEL K160603

    Patients

    Seq Age Sex Outcome Treatment
    1 Other