BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM

    MDR report key: 3190007 · Received June 26, 2013

    Report

    Report Number
    2530088-2013-00982
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    March 15, 2012
    Report Date
    April 5, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    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. (B)(6). A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. OUR INVESTIGATION HAS SHOWN THAT THE THIRST THREAD FLANK AT THE TOP OF THE SCREW IS PARTIALLY BROKEN OFF. THE DAMAGE INDICATES THAT THE HEAD WAS NOT PROPERLY FIXED AT THE SCREW AND FELL OFF DURING INSERTION AS REPORTED. WE ASSUME THAT THE THREAD FLANK WAS DAMAGED BY A LOOSE PRIMELOCK CONNECTION BETWEEN THE RETAINING SLEEVE AND THE SCREW DURING INSERTION. SUCH A LOOSE CONNECTION, IN COMBINATION WITH HIGH LATERAL STRESS, CAN LEAD TO SUCH A BREAKAGE. THE CAUSE OF THE LOOSE CONNECTION IS EITHER INSUFFICIENT TIGHTENING DURING THE SCREW PICK UP OR HIGH FRICTION BETWEEN THE INNER AND OUTER SLEEVE OF THE RETAINING SLEEVE. OUR PRODUCT DEVELOPMENT CENTRE DID IMPROVE THE DESIGN OF THE RETAINING SLEEVES MEANWHILE TO REDUCE FRICTION BETWEEN THE SLEEVES. ALTHOUGH WE ARE UNABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE, THE CAUSE OF THE LOOSE CONNECTION IS EITHER INSUFFICIENT TIGHTENING DURING THE SCREW PICK UP OR HIGH FRICTION BETWEEN THE INNER AND OUTER SLEEVE OF THE RETAINING SLEEVE.

    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. ADDITIONAL INFORMATION: THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. NO MANUFACTURING DEFICIENCIES WERE NOTED.

    Description of Event or Problem · 1

    IMPLANT CAME APART, THE SLEEVE CAME LOOSE FROM SCREW DURING IMPLANTATION. THIS IS 1 OF 1 REPORT FOR EVENT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290424 PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM NKB SYNTHES BRANDYWINE 6617455

    Patients

    Seq Age Sex Outcome Treatment
    1