BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIX LOCKING CAP

    MDR report key: 3082849 · Received April 29, 2013

    Report

    Report Number
    2530088-2013-10545
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    August 2, 2012
    Report Date
    August 2, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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. PLACEHOLDER.

    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). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PRODUCT DEVELOPMENT EVENT EVALUATION, AFTER REVIEWING THE COMPLAINT DESCRIPTION, IT IS NOT CLEAR AS TO WHETHER THE SURGEON USED THE TORQUE-LIMITING HANDLE WHEN REMOVING THE ALREADY TIGHTENED LOCKING CAPS. THE FRACTURE AT THE TIP IMPLIES THAT THERE WAS POTENTIALLY EXCESSIVE TORQUE APPLIED TO THE DRIVER EXCEEDING THE YIELD AND SHEAR STRENGTH. AS IT IS NOT KNOWN HOW MUCH TORQUE WAS APPLIED TO THESE DRIVERS, THIS COMPLAINT IS DEEMED INDETERMINATE.

    Description of Event or Problem · 1

    THE CONSULTANT REPORTS REGARDING THE REPAIR OF A SACRAL FRACTURE. ON (B)(6) 2012, THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR REPAIR OF THE SACRAL FRACTURE. DURING THE PROCEDURE, 8 MATRIX LOCKING CAPS WERE REMOVED. IT WAS NOTED THAT ONE OF THE 8 WAS STUCK AND DIFFICULT TO REMOVE, BUT THE SURGEON WAS ABLE TO REMOVE IT. THE CONSULTANT REPORTS THAT THE SURGEON STATED THAT THERE WAS NO HARDWARE FAILURE. DURING THE PROCEDURE, THE TIPS ON 2 SCREW DRIVERS BROKE. THERE WERE NO PIECES TO RETRIEVE. THE SURGEON WAS ABLE TO USE OTHER SCREW DRIVERS TO COMPLETE THE SURGERY WITHOUT FURTHER INCIDENT. DURING THE PROCEDURE, THE SURGEON ADDED BONE GRAFT AND DECOMPRESSION AT THE SITE OF THE FRACTURE, AND IMPLANTED 2 NEW RODS AND 8 NEW LOCKING CAPS. NO INJURY TO THE PATIENT WAS NOTED. THIS IS 1 OF 3 REPORT FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184426 TI MATRIX LOCKING CAP NKB SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1