BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8.0MM TI MATRIX SCREW 40MM THREAD LENGTH

    MDR report key: 3083302 · Received April 29, 2013

    Report

    Report Number
    2530088-2013-10512
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    October 25, 2011
    Report Date
    October 25, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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. THE DEVICE WAS RETURNED FOR A MANUFACTURING EVALUATION AND THE THREADS LOCATED ON THE ID OF THE HEAD OF THE SCREW WERE DAMAGED, WITH A SMALL PORTION BROKEN AWAY FROM THE SCREW BUT STILL ATTACHED. DUE TO DAMAGE, THE DIMENSIONS PERTINENT TO THIS COMPLAINT COULD NOT BE EVALUATED. THEREFORE, (CONTINUED ON PAGE 3) THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING STANDPOINT. PRODUCT DEVELOPMENT EVENT EVALUATION REVEALED THAT THE FAILURE MECHANISM DISPLAYED COULD ONLY BE ACHIEVED THROUGH AN APPLIED TENSILE LOAD. THE CONDITION OF THE SCREW, AS WELL AS THE COMPLAINT DESCRIPTION, INDICATES SUCH A LOAD RESULTED FROM A THREAD INTERFACE MISALIGNMENT DURING LOADING OF THE SCREW, COMMONLY KNOWN AS CROSS-THREADING. THIS MISALIGNMENT CAUSED ABNORMAL FORCES TO CONCENTRATE ON THE IDENTIFIED THREADS, EXCEEDING THE DESIGNS TENSILE LIMITS AND CAUSING THEM TO PEEL AWAY FROM THE IMPLANT. 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 AND UNLOADING SCREWS FROM A HOLDING SLEEVE. IMPROPER TECHNIQUE WAS THE LIKELY CAUSE OF FAILURE. HOWEVER, WITHOUT INSPECTION OF THE HOLDING SLEEVE, THE COMPLAINT IS INDETERMINATE FROM A DESIGN STANDPOINT. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A POSTERIOR LUMBAR INTERBODY FUSION PROCEDURE USING THE SPINE MATRIX DEGEN SET, THE SURGEON WAS INSERTING THE SCREW INTO THE PEDICLE AND THE SCREW BROKE AT THE INTERFACE OF THE SCREWDRIVER SHAFT, THE THREADED SLEEVE, AND THE THREAD OF THE BONE SCREW. THIS HAPPENED WITH 2 DIFFERENT SCREWS. THE SURGEON THEN SELECTED 2 MORE SCREWS FROM THE SET AND WAS ABLE TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS. NOTHING BROKE INTO THE WOUND AND THERE WAS NOTHING TO RETRIEVE. THIS IS REPORT 1 OF 2 FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184045 8.0MM TI MATRIX SCREW 40MM THREAD LENGTH NKB SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1