BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.0MM TI MATRIX SCREW 55MM THREAD LENGTH

    MDR report key: 3031621 · Received April 2, 2013

    Report

    Report Number
    2530088-2013-10352
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    April 17, 2012
    Report Date
    April 17, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE VISUAL MANUFACTURING EVALUATION NOTED THAT THE SCREW WAS RECEIVED WITH APPROXIMATELY WITH 75% OF THE THREAD PEELED FROM THE TOP OF THE SPHERICAL OUTER DIAMETER, ANODIZE IS MISSING FROM THIS AREA. THE PEELED THREAD WAS STILL ATTACHED TO THE SCREW. IT WAS OBSERVED THE SD25 FACE HAS NICKS AND SCRATCHES. IN ADDITION ON THE BEAD BLASTED SPHERICAL OUTER DIAMETER THERE IS A FLATTENED AREA INDICATING THE BODY ASSEMBLY WAS AT ONE TIME INSTALLED. NO DIMENSIONAL MEASUREMENTS COULD BE TAKEN BECAUSE OF DAMAGE; THEREFORE, THE COMPLAINT IS CONSIDERED INDETERMINATE. THE INVESTIGATION FOUND THAT ALL DESCRIBED NONCONFORMITIES WOULD BE POST MANUFACTURING. THE PRODUCT DEVELOPMENT EVALUATION STATED THAT THE CONDITION OF WHICH THE SCREW WAS RECEIVED, INDICATED THAT THE ENGAGED HOLDING SLEEVE WAS PARTIALLY UNTHREADED FROM THE IMPLANT INTERFACE, AT WHICH POINT A CANTILEVER LOAD WAS APPLIED TO ASSEMBLY. THIS INCOMPLETE ENGAGEMENT ALLOWED THE CANTILEVER FORCE TO CONCENTRATE ON ONE SECTION OF THE IDENTIFIED THREADS, EXCEEDING THE DESIGN'S TENSILE LIMITS. IT WAS ALSO, OBSERVED THAT THE FIRST FULL THREAD OF THE IMPLANT-HOLDING SLEEVE THREADED INTERFACE HAS PEELED AWAY FROM THE HEAD OF THE BONESCREW. THE DAMAGE EXHIBITED ON THE IMPLANT CAN ONLY BE ACHIEVED THROUGH AN APPLIED TENSILE LOAD, CAUSING THE DISPLAYED MECHANISM FAILURE. NO OTHER EVIDENCE OF DAMAGE WAS OBSERVED. THE MATRIX TECHNIQUE GUIDE AS WELL AS OTHER PRODUCT SUPPORT INFORMATION FULLY ILLUSTRATES THE PROPER METHOD OF LOADING / UNLOADING SCREWS FROM A LOCKABLE HOLDING SLEEVE. IMPROPER TECHNIQUE RESULTING IN PROPAGATION OF FORCES EXCEEDING THE DESIGN'S INTENDED LIMITS WAS THE LIKELY CAUSE OF FAILURE. HOWEVER, THE ASSEMBLY CONFIGURATION OF THE HOLDING SLEEVE & PEDICLE SCREW CANNOT BE VERIFIED AND SO THE COMPLAINT MUST BE RENDERED INDETERMINATE.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(4)

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE DURING POSTERIOR LUMBAR FUSION (PLF) PROCEDURE AT L5-S1 THE EDGE OF TWO 2 SCREWS BEGAN TO PEEL OFF. THE HOLDING SLEEVE BROKE OFF AT TIP AND THE TIP OF THE STARDRIVE SHAFT IS ROUNDED, SO IT WILL NOT ENGAGE THE SCREW. NONE OF THESE INSTRUMENTS CAUSED HARM TO THE PATIENT, NOTHING WAS BROKEN INTO THE WOUND AND NOTHING TO RETRIEVE. CONSULTANT ALSO REPORTS THE CURETTES ARE DULL. THIS IS 1 OF 3 REPORTS FOR THE SAME INCIDENT.

    Description of Event or Problem · 1

    THIS REPORT IS FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133997 7.0MM TI MATRIX SCREW 55MM THREAD LENGTH NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1