BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARIAX DR AIMING BLOCK FIXATION PIN

    MDR report key: 3951688 · Received July 23, 2014

    Report

    Report Number
    0008010177-2014-00187
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 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 REVEALED THE VARIAX DR AIMING BLOCK FIXATION PIN TO BE THE SUBJECT PRODUCT. NO FURTHER ASSOCIATED PRODUCTS WERE REPORTED. REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO DISCREPANCIES. THE ITEM RETURNED WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. DURING INVESTIGATION NO MATERIAL, DESIGN OR MANUFACTURING RELATED ISSUES WERE FOUND. 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 NC ID # (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 NON-CONFORMITY WAS IDENTIFIED.

    Description of Event or Problem · 1

    DURING THE INSPECTION OF THE RETURNED LONER INSTRUMENTS FROM THE HOSPITAL, IT WAS FOUND THAT THE FIXATION PIN WAS BROKEN. ACCORDING TO THE SR, THERE WERE NO ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    DURING THE INSPECTION OF THE RETURNED LONER INSTRUMENTS FROM THE HOSPITAL, IT WAS FOUND THAT THE FIXATION PIN WAS BROKEN. ACCORDING TO THE SR, THERE WERE NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430508 VARIAX DR AIMING BLOCK FIXATION PIN PLATE, FIXATION, BONE HRS STRYKER LEIBINGER FREIBURG (MDR) AD03

    Patients

    Seq Age Sex Outcome Treatment
    1 Other