BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAL SPACER HANDLE

    MDR report key: 3002481 · Received March 13, 2013

    Report

    Report Number
    1719045-2013-10348
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    January 19, 2012
    Report Date
    February 2, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    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 THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE MANUFACTURING EVALUATION REVEALED THAT DUE TO AN UNKNOWN CAUSE, THE SPINDLE HAS A BROKEN THREADED TIP AND THERE ARE SLIGHT RUB MARKS ALONG THE SHAFT OF THE SPINDLE. THE SLEEVE EXHIBITS SLIGHT RUB MARKS. THE TIP HAS STAIN (CORROSION / CONTAMINATION) ON THE SURFACE AND THE KNOB, HAS RUB MARKS AND SOME MINOR SCRATCHES ON THE BACK SURFACE. IT IS CONCLUDED THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT. THE PRODUCT DEVELOPMENT INVESTIGATION SHOWED THE OUTER HANDLE ASSEMBLY OF THE INSTRUMENT APPEARS TO BE IN GOOD CONDITION, WITH NO VISUAL INDICATORS OF WEAR AND TEAR FROM USE. HOWEVER, A PORTION OF THE THREADED SPINDLE COMPONENT TIP IS BROKEN OFF, WITH APPROXIMATELY 3.5MM OF THE THREADED END REMAINING ON THE INSTRUMENT. THE KNOB OF THE SPINDLE COMPONENT ALSO HAS SCUFF MARKS ON ITS IMPACTION SURFACE INDICATING USE. ALSO, THE SPINDLE DOES NOT HAVE THE SYNTHES LOGO OR PART NUMBER 03.802.151 ETCHED ON IT, WHICH IS A CLEAR INDICATOR THAT THE INSTRUMENT IS NOT THE LATEST DRAWING (REV E) WHERE THESE MARKINGS WERE INTRODUCED. AN INTERNAL CORRECTIVE 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. ORIGINAL AWARENESS DATE IS (B)(6) 2012.

    Description of Event or Problem · 1

    SYNTHES (B)(4) MANAGER REPORTED THAT DURING AND ANTERIOR LUMBAR DISCECTOMY AND FUSION WITH SYNFIX-LR, THE SURGEON WAS USING THE TRIAL SPACER HANDLE, AND THE TIP OF THE THREADED END BROKE OFF IN THE TRIAL SPACER. THE SURGEON WAS ABLE TO REMOVE THE BROKEN TIP AND HANDLE WITHOUT ANY HARM OCCURRING TO THE PATIENT.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105770 TRIAL SPACER HANDLE LXH SYNTHES MONUMENT 6652107

    Patients

    Seq Age Sex Outcome Treatment
    1