BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING SLEEVE-STANDARD FOR MATRIX

    MDR report key: 3062948 · Received April 17, 2013

    Report

    Report Number
    1719045-2013-10669
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    September 6, 2011
    Report Date
    September 23, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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. PRODUCT DEVELOPMENT EVALUATION REVEALS THE PART WAS RECEIVED WITH THE FIRST THREAD ON THE DISTAL END BROKEN OFF AND THE REMAINING THREADS HAVE DENTS AND BURRS. THE TIP CANNOT BE INSERTED INTO A SCREW DUE TO THE DAMAGE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE TECHNIQUE GUIDE ILLUSTRATES HOW TO PROPERLY LOAD AND TIGHTEN THE HOLDING SLEEVE INTO THE RECESS OF THE SCREW AND CAUTIONS NOT TO GRASP THE GREEN KNOB DURING SCREW INSERTION AS THIS WILL CAUSE THE HOLDING SLEEVE TO DISENGAGE FROM THE SCREW. THIS ISSUE WAS PREVIOUSLY EVALUATED AND DEEMED VALID. PREVIOUS EVALUATION NOTES, THE CONDITION OF THE THREADS INDICATES THAT THE ENGAGED HOLDING SLEEVE WAS PARTIALLY UNTHREADED FROM THE IMPLANT INTERFACE, AT WHICH POINT A CANTILEVER LOAD WAS APPLIED TO THE ASSEMBLY. THIS INCOMPLETE ENGAGEMENT ALLOWED THE CANTILEVER FORCE TO CONCENTRATE ON ONE SECTION OF THE THREADS, EXCEEDING THE DESIGN LIMITS. THE BREAKAGE IS DUE TO THIS CONDITION. THE CONDITION APPEARS TO BE THE RESULT OF THE SLEEVE BECOMING LOOSE DURING SCREW INSERTION WHICH CONTRIBUTED TO THE BREAKAGE. AN INTERNAL ACTION HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FUSION PROCEDURE AT T3-PELVIS, THE THREADED TIP AT THE END OF THE HOLDING SLEEVE BROKE OFF WHILE THE SURGEON WAS THREADING ON A SCREW. THE TIPS OF THE CORONAL BENDERS BROKE OFF AS THE SURGEON WAS BENDING A ROD. THE BROKEN PIECES DID NOT FALL INTO THE PATIENT. THE SURGEON USED OTHER INSTRUMENTS TO COMPLETE THE PROCEDURE WITHOUT PATIENT HARM. THIS IS 1 OF 3 REPORTS FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164774 HOLDING SLEEVE-STANDARD FOR MATRIX LXH SYNTHES MONUMENT 6489721

    Patients

    Seq Age Sex Outcome Treatment
    1