BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING SLEEVE-STANDARD FOR MATRIX

    MDR report key: 3071873 · Received April 22, 2013

    Report

    Report Number
    1719045-2013-10760
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    December 17, 2011
    Report Date
    December 17, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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. ORIGINAL AWARENESS DATE IS (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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 PRODUCT DEVELOPMENT EVALUATION REVEALED THAT THE FIRST TWO THREADS ON THE DISTAL END ARE PARTIALLY STRIPPED AND THE REMAINING THREADS HAVE DENTS AND BURRS. THE TIP CANNOT 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 DAMAGE IS CONSISTENT WITH THAT NOTED IN PREVIOUS COMPLAINTS AND THAT EVALUATION STATES THAT 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 AND AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THIS ISSUE. THE CONDITION APPEARS TO BE THE RESULT OF THE SLEEVE BECOMING LOOSE DURING SCREW INSERTION WHICH CONTRIBUTED TO THE BREAKAGE. THIS CONDITION IS BEING ADDRESSED AND IS VALID BASED ON THE NUMBER OF COMPLAINTS RECEIVED FOR THIS CONDITION.

    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 AN UNKNOWN PROCEDURE, A PEDICLE PROBE BENT, THE TIP OF A LONG HOLDING SLEEVE BROKE OFF, AND THE HEADS OF TWO SCREWS BROKE OFF WHILE USING TWO STANDARD HOLDING SLEEVES. ALL BROKEN PIECES WERE RETRIEVED. ALL ITEMS ARE AVAILABLE FOR RETURN. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172781 HOLDING SLEEVE-STANDARD FOR MATRIX LXH SYNTHES MONUMENT 6558993

    Patients

    Seq Age Sex Outcome Treatment
    1