BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.0MM TI MATRIX POLYAXIAL SCREW 45MM THREAD LENGTH

    MDR report key: 3072432 · Received April 23, 2013

    Report

    Report Number
    2530088-2013-10452
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    November 30, 2011
    Report Date
    November 30, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    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. ADDITIONAL PRODUCT CODES: MNH, MNI, KWQ, KWP. AFTER REVIEWING THE DHR FOR ALL MATERIAL, COMPONENTS AND ASSEMBLIES, NO DISCREPANCIES WERE FOUND THAT COULD BE RELATED TO THE COMPLAINT CONDITION. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED THAT THE COLLET IS ROTATED APPROXIMATELY NINETY DEGREES TO ITS PROPER POSITION. THERE ARE MARKS IN THE STARDRIVE RECESS AND THE INTERNAL THREADS IN THE SCREW HEAD THAT INDICATE THE HOLDING SLEEVE AND SCREWDRIVER WERE INSERTED INTO THE SCREW DURING THE PROCEDURE. THE COLLET WAS ROTATED INTO PROPER POSITION USING AN ALIGNMENT TOOL FROM THE PRODUCT DEVELOPMENT DISPLAY SET. THE POLYAXIAL SCREWS ARE ASSEMBLED WITH THE COLLET ALIGNED PROPERLY AND A HEAD POSITIONING TOOL IS PROVIDED IN THE SET. THE TECHNIQUE GUIDE RECOMMENDS CONFIRMING THE POSITION PRIOR TO INSERTING THE RODS AND AN INSTRUMENT IS PROVIDED TO CORRECT ANY MISALIGNMENT THAT MAY BE ENCOUNTERED. USING THE POSITIONING INSTRUMENT, THE COLLET ON THE RETURNED DEVICE CAN BE RETURNED TO ITS PROPER POSITION EASILY. THIS COMPLAINT IS DEEMED INVALID.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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

    IT WAS REPORTED THAT DURING A TLIP AT L4-L5, S1, DURING SCREW INSERTION THE TIP OF THE SCREWDRIVER BROKE. BROKEN PIECES WERE RETRIVED FROM PATIENT, NO HARM TO PATIENT. WHILE PLACING THE PEDICLE SCREW AT S1, SURGEON NOTICED THE COLLAR INSIDE THE SCREW WAS TURNED SIDEWAYS. THE SURGEON BACKED OUT THE SCREW AND SELECTED ANOTHER SCREW. PROCEDURE WAS COMPLETED WITH NO FURTHER PROBLEMS. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173763 7.0MM TI MATRIX POLYAXIAL SCREW 45MM THREAD LENGTH NKB SYNTHES BRANDYWINE 6762962

    Patients

    Seq Age Sex Outcome Treatment
    1