BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARIAX DR AIMING BLOCK JOYSTICK

    MDR report key: 3994207 · Received August 8, 2014

    Report

    Report Number
    0008010177-2014-00210
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 15, 2014
    Manufacturer
    STRYKER LEIBINGER FREIBURG (MDR)
    Product Code
    HRS
    PMA / PMN Number
    K112455
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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: THE EVALUATION REVEALED THE JOYSTICK AND THE SCREW OF THE FIXATION PIN AS PRIMARY PRODUCTS. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR) FOR THE JOYSTICK, THE JOYSTICK RETURNED WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. AS THE JOYSTICK HAD BEEN IN USE FOR APPROX. 2 YEARS WE PRE-SUPPOSE THAT IT HAD FULFILLED ITS TASKS IN FORMER SURGERIES AS INTENDED. DURING INVESTIGATION NO MATERIAL, DESIGN OR MANUFACTURING RELATED ISSUES WERE FOUND. THE JAMMING OF THE SCREW WITHIN THE JOYSTICK WAS CONFIRMED; IT WAS NOT POSSIBLE TO DISASSEMBLE BOTH ITEMS DURING INVESTIGATION. PREVIOUS CASES ARE KNOWN REPORTING JAMMING FIXATION PINS. ROOT CAUSES WERE TOO HIGH TORSION FORCES, BODY RESIDUES ON THE TREAD WINDINGS AND OBLIQUE INSERTION. ALL CAUSES ARE USER RELATED. BECAUSE NO MANUFACTURING FAULT WAS DETECTED THE CASE IS ALSO ATTRIBUTED TO THE USER. NO NONCONFORMITY IDENTIFIED.

    Description of Event or Problem · 1

    DURING THE INSPECTION, IT WAS FOUND THAT THE FIXATION PIN WAS BROKEN. ITS INNER PART WAS NOT ABLE TO BE REMOVED FROM THE JOYSTICK AND ITS OUTER PART WAS MISSING.

    Description of Event or Problem · 1

    DURING THE INSPECTION, IT WAS FOUND THAT THE FIXATION PIN WAS BROKEN. ITS INNER PART WAS NOT ABLE TO BE REMOVED FROM THE JOYSTICK AND ITS OUTER PART WAS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468460 VARIAX DR AIMING BLOCK JOYSTICK PLATE, FIXATION, BONE HRS STRYKER LEIBINGER FREIBURG (MDR) AC08

    Patients

    Seq Age Sex Outcome Treatment
    1 Other