BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARIAX DR AIMING BLOCK FIXATION PIN

    MDR report key: 3940564 · Received July 17, 2014

    Report

    Report Number
    0008010177-2014-00181
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 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 AND THE VARIAX DR AIMING BLOCK JOYSTICK TO BE THE SUBJECT PRODUCTS. NO FURTHER ASSOCIATED PRODUCTS WERE REPORTED. REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO DISCREPANCIES. THE ITEMS RETURNED WERE DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. DURING INVESTIGATION NO MATERIAL, DESIGN OR MANUFACTURING RELATED ISSUES WERE FOUND. REGARDING THE BROKEN STOP PIN: 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. REGARDING THE STUCK SCREW IN THE JOYSTICK: 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 NON-CONFORMITY WAS IDENTIFIED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, VARIAX DR SURGERY WAS PERFORMED. AFTER THE REMOVAL OF FIXATION PIN FROM AIMING BLOCK, THE FIXATION PIN WAS FOUND TO BE BROKEN. WHEN THE FIXATION PIN WAS ATTACHED TO THE PLATE AND THE AIMING BLOCK, THERE WAS NO PROBLEM. NEW INFORMATION: THE PART OF THE BROKEN FIXATION PIN COULD NOT BE REMOVED FROM A JOY STICK.

    Description of Event or Problem · 1

    ON (B)(6) 2014, VARIAX DR SURGERY WAS PERFORMED. AFTER THE REMOVAL OF FIXATION PIN FROM AIMING BLOCK, THE FIXATION PIN WAS FOUND TO BE BROKEN. WHEN THE FIXATION PIN WAS ATTACHED TO THE PLATE AND THE AIMING BLOCK, THERE WAS NO PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418876 VARIAX DR AIMING BLOCK FIXATION PIN PLATE, FIXATION, BONE HRS STRYKER LEIBINGER FREIBURG (MDR) AD09

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other