BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARIAX DR AIMING BLOCK FIXATION PIN

    MDR report key: 4120540 · Received September 26, 2014

    Report

    Report Number
    0008010177-2014-00277
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 25, 2014
    Report Date
    September 4, 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

    THE EVALUATION REVEALED THE FIXATION PIN TO BE THE PRIMARY PRODUCT. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR); THE FIXATION PIN RETURNED WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. AS THE PIN HAD BEEN IN USE FOR APPROX. ONE YEAR WE PRE-SUPPOSE THAT IT HAD FULFILLED ITS TASKS IN FORMER SURGERIES AS INTENDED. VISUAL EXAMINATION OF THE DEVICE REVEALED THE STOP PIN, WHICH WAS LASER-WELDED TO THE EXPANDING SLEEVE TO BE BROKEN OFF DUE TO TOO HIGH BENDING FORCES AND THEREFORE DETACHED. THE BROKEN OFF STOP PIN WAS RETURNED AS WELL. THE BREAKAGE SURFACE OF THE WELDING SEAM BETWEEN THE STOP PIN AND THE EXPANDING SLEEVE SHOWED THE APPEARANCE OF A FORCED RUPTURE. THE GEOMETRY OF THE WELDING SEAM INDICATED THAT THE LASER-WELDING SEAM WAS PERFORMED CORRECTLY. DUE TO TOO HIGH TORSIONAL FORCES, WHICH WERE APPLIED SEVERAL TIMES, TOO HIGH BENDING FORCES HAD OCCURRED UPON TO THE STOP PIN, WHICH FINALLY HAD LED TO THE BREAKAGE OF THE LASER-WELDING SEAM BETWEEN THE STOP PIN AND THE EXPANDING SLEEVE. INDICATIONS FOR MATERIAL OR MANUFACTURING RELATED ISSUES WERE NOT FOUND IN THE INVESTIGATION. THEREFORE NO CORRECTIVE ACTION WAS DEEMED NECESSARY AT THIS TIME. HOWEVER DUE TO A NEGATIVE COMPLAINT DEVELOPMENT OF THE AFFECTED FIXATION PIN, A NON-CONFORMITY (B)(4) WAS ALREADY BEEN RAISED FOR ADDITIONAL ANALYSIS. THE NC WAS TRANSFERRED INTO CAPA ID # (B)(4). THE CAPA IS STILL ONGOING. BASED ON THE ABOVE FACTS THE ROOT CAUSE OF THE REPORTED EVENT WAS NOT RELATED TO A DEFICIENCY OF THE DEVICE, BUT WAS RATHER LINKED TO AN INADEQUATE HANDLING BY THE USER. DUE TO TOO HIGH BENDING FORCES, THE LASER-WELDED SEAM BETWEEN THE STOP PIN AND THE EXPANDING SLEEVE HAD BROKEN OFF IN A LOW CYCLE FATIGUE MODE WITH EVIDENCE OF A FORCED RUPTURE. NO NONCONFORMITY IDENTIFIED.

    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

    DURING VARIAX DR SURGERY, A FIXATION PIN WAS BROKEN WHEN IT WAS REMOVED FROM A PLATE AFTER SCREW INSERTION.

    Description of Event or Problem · 1

    DURING VARIAX DR SURGERY, A FIXATION PIN WAS BROKEN WHEN IT WAS REMOVED FROM A PLATE AFTER SCREW INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600330 VARIAX DR AIMING BLOCK FIXATION PIN PLATE, FIXATION, BONE HRS STRYKER LEIBINGER FREIBURG (MDR) AD03

    Patients

    Seq Age Sex Outcome Treatment
    1 Other