BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING SLEEVE-LONG FOR MATRIX

    MDR report key: 3070361 · Received April 22, 2013

    Report

    Report Number
    1719045-2013-10714
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    December 13, 2011
    Report Date
    December 13, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RECEIVED FOR A PRODUCT DEVELOPMENT EVALUATION AND THE FIRST THREAD ON THE DISTAL END WAS PARTIALLY SHEARED OFF. THE REMAINING THREADS APPEARED TO BE UNDAMAGED. THE TIP COULD NOT BE INSERTED INTO A SCREW DUE TO THE DAMAGE. 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. THE CONDITION APPEARS TO BE THE RESULT OF THE SLEEVE BECOMING LOOSE DURING SCREW INSERTION WHICH CONTRIBUTED TO THE BREAKAGE. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THIS ISSUE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A POSTERIOR LUMBAR PEDICLE SCREW PROCEDURE, THE THREADS ON A HOLDING SLEEVE PEELED OFF. A BACKUP WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY HARM TO THE PATIENT. THIS REPORT IS FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172814 HOLDING SLEEVE-LONG FOR MATRIX LXH SYNTHES MONUMENT 6489805

    Patients

    Seq Age Sex Outcome Treatment
    1