BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIX THREADED PERSUADER- STANDARD

    MDR report key: 3082253 · Received April 29, 2013

    Report

    Report Number
    1719045-2013-10976
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    November 3, 2011
    Report Date
    November 3, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. THE PRODUCT DEVELOPMENT EVALUATION REVEALED THAT THE HEX DRIVE ADAPTER DID NOT BREAK OFF INSIDE THE PERSUADER AS REPORTED. ALL OF THE FINGERS ARE BROKEN OFF THE REDUCTION INSERT OF THE PERSUADER. THE DEVICE EXHIBITS NO OTHER VISUALLY OBVIOUS DAMAGE. AS NOTED, IMPROPER ASSEMBLY OF THE INSTRUMENT (NOT FULLY SEATING THE INSERT) BY THE OPERATOR LIKELY CAUSED THE REDUCTION INSERT TO SEE EXCESSIVE LOADING IN THE REGION OF FAILURE DURING REDUCTION. RATHER THAN HAVING THE AXIAL LOADS REACTED BY THE THRUST SURFACE ON THE UNDERSIDE OF THE HEAD, THE FINGERS INSTEAD CONTACT THE RETENTION RIB AND ARE SQUEEZED INTO THE INNER TUBE AS REDUCTION LOADS ARE APPLIED POTENTIALLY CAUSING THEM TO BREAK.

    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. FEMALE, PATIENT AGE AT TIME OF EVENT WAS GIVEN AS APPROXIMATELY (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A POSTERIOR LUMBAR INTERBODY FUSION (PLIF) L3-S1 PROCEDURE, AS THE SURGEON WAS REDUCING THE (03.620.091) HEX DRIVE ADAPTER BROKE OFF INSIDE (03.632.008) THE THREADED PERSUADER; THE SURGEON USED 4 DIFFERENT STARDRIVE SCREWDRIVER SHAFTS (03.632.004), (03.632.002), (03.632.072 - X2) TO REMOVE A CAP AND ALL THREE SCREWDRIVER SHAFTS BECAME STRIPPED. THE CAP WAS LEFT IN PLACE, AND IT REMAINS IN THE PATIENT. THE SURGEON INTENDED TO REMOVE THE CAP AT S1 ALLOWING HIM TO THE ROD AND CONTOUR IT; HOWEVER, THE SURGEON WAS ABLE TO GET THE ROD TO CONTOUR AS THE OTHER CAPS WERE LOCKED DOWN. THIS IS REPORT 1 OF 6 FOR THE SAME EVENT. SYNTHES COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185126 MATRIX THREADED PERSUADER- STANDARD LXH SYNTHES MONUMENT 6390309

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention