BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM

    MDR report key: 2944117 · Received February 5, 2013

    Report

    Report Number
    2530088-2013-00110
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    December 13, 2012
    Report Date
    January 10, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. PRODUCT RECEIVED ASSEMBLED, HEAD, BODY ASSEMBLY, ATTACHED. EVALUATOR ATTEMPTED TO MANUALLY REMOVE THE BODY FROM THE SCREW AND WAS UNABLE TO REMOVE. THERE ARE VISUAL DEFORMATIONS - NICKS AND SCRATCHES WITH ANODIZE FINISHED REMOVED ON THE M6.5 X 0.75-6H THREAD ON THE SCREW, ALSO THE SD25 FACE HAS NICK AND SCRATCHES. THE BODY ALSO HAS NICKS AND SCRATCHES ON THE OUTER SURFACE. ALL DESCRIBED NONCONFORMITIES ARE POST MANUFACTURING. WITH PRODUCT ASSEMBLED, NO DIMENSIONS COULD BE MEASURED, AND EVEN IF BODY COULD BE REMOVED FROM SCREW, THE SPHERICAL OUTER DIAMETER ON THE SCREW CANNOT BE MEASURED BECAUSE THE DIMENSION APPLIES AFTER ANODIZE BUT PRIOR TO BEAD BLAST AND THE COLLET IS IN ITS MANUFACTURED SPLIT CONDITION AND CANNOT BE MEASURED.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. REVIEW OF THE DHRS SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. WE HAVE SENT THE COMPLAINED PEDICLE SCREW TO THE RESPONSIBLE PRODUCT MANAGER FOR INVESTIGATION; HERE THE RESULT: THE FIRST PRIMELOCK THREAD OF THE BONE SCREW IS BROKEN AWAY ON 50 PERCENT OF THE CIRCUMFERENCE. THE BROKEN PART IS RETRIEVED. THE SCREW HEAD IS OF THE LATEST GENERATION WITH UPDATED COLLET, SCREW HEAD INTERFACE. A POSSIBLE CAUSE FOR THE RELEASE OF THE SCREW HEAD FROM THE BONE SCREW IS THE DAMAGE OF THE RIM OF THE BONE SCREW. AN INTACT SPHERICAL HEAD OF THE BONE SCREW IS IMPORTANT FOR CORRECT RETENTION OF THE SCREW HEAD. ACCORDING TO THE REPORTED CIRCUMSTANCES, A CROSS THREADING BETWEEN THE TIP OF THE RETAINING SLEEVE AND THE THREAD OF THE BONE SCREW OCCURRED AND POSSIBLY THE RIM OF THE BONE SCREW WAS SUBSEQUENTLY DAMAGED. ALTERNATIVELY IT IS POSSIBLE THAT THE TIP OF THE RETAINING SLEEVE WAS NOT SUFFICIENTLY TIGHTENED INTO THE PRIMELOCK THREAD OF THE BONE SCREW. ALTERNATIVELY IT IS ALSO POSSIBLE, THAT THE PRIMELOCK CONNECTION BETWEEN RETAINING SLEEVE AND BONE SCREW WAS INADVERTENTLY LOOSENED BY GRASPING THE GREEN KNOB DURING SCREW INSERTION. THE TWO LATTER POSSIBILITIES LEAD TO INSUFFICIENT ENGAGEMENT OF THE THREAD FLANKS IN THE PRIMELOCK THREAD OF THE BONE SCREW. IN COMBINATION WITH HIGH LATERAL FORCES, E.G. BY EXCESSIVE CORRECTION OF SCREW TRAJECTORY, SOFT TISSUE PUSH OR STRONG DISTRACTION FORCES, IT CAN LEAD TO OVERLOAD AND BREAKING OF THE REMAINING ENGAGED THREAD FLANKS. THE SURGICAL TECHNIQUE 036.001.185 VERSION AB DESCRIBES THE HANDLING OF THE RETAINING SLEEVE DURING SCREW INSERTION ON PAGE 12. IN ADDITION SYNTHES OFFERS THE LOCKING RETAINING SLEEVE, 03.616.043/03.632.042, AN ALTERNATIVE INSTRUMENT WHICH MAY BE GRASPED IN THE AREA OF THE KNOB DURING SCREW INSERTION. REVIEWING THE MANUFACTURING AND MATERIAL DOCUMENTATION SHOWS CONFORMITY AS WELL. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: SURGEON WAS INSERTING A MATRIX PEDICLE SCREW AND IT WAS ATTACHED OBLIQUELY. SURGEON WAS ASKED TO SET THE SCREW ON THE DRIVER CORRECTLY. AS SURGEON WAS INSERTING THE SCREW AGAIN, THE SCREW HEAD WAS FOUND TO BE COMING OFF. NO FURTHER INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 1

    THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48592 PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM PEDICSCR MATRIX NKB SYNTHES BRANDYWINE 8057133

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR