BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING SLEEVE-LONG FOR MATRIX

    MDR report key: 2872182 · Received December 13, 2012

    Report

    Report Number
    1719045-2012-01360
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 14, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR LOT # 6583190 REVEALED THE HOLDING SLEEVE-LONG FOR MATRIX WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET NUMBER ON 5/19/2011. THE PRODUCT CONFORMED TO ALL REQUIREMENTS.

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT EVALUATION WAS CONDUCTED. THE 03.632.036 WAS RETURNED WITH APPROXIMATELY 0.5MM LENGTH OF THREAD BROKEN OFF. THE BREAKAGE INDICATES THAT THE HOLDING SLEEVE MAY HAVE BEEN PARTIALLY UNTHREADED DURING THE INSERTION OF THE POLYAXIAL SCREW ALLOWING FOR A BENDING MOMENT TO BE APPLIED EXCEEDING THE TENSILE STRENGTH OF THE THREADED REGION. THE FAILURE OCCURRED DUE TO EXCESSIVE FORCE BEING APPLIED IN THE PARTIALLY UNTHREADED STATE. A CAPA HAS BEEN INITIATED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    AN ACCOUNT IN (B)(6) REPORTED THE THREADED PORTION OF THE HOLDING SLEEVE BROKE WHEN INSERTING UNKNOWN MATRIX POLYAXIAL SCREWS. THE BROKEN PORTION WAS RETRIEVED AND THROWN AWAY. THE CASE PROCEEDED WITHOUT FURTHER INCIDENT USING A SECOND HOLDING SLEEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOLDING SLEEVE-LONG FOR MATRIX HOLDING SLEEVE-LONG FOR MATRIX LXH SYNTHES MONUMENT 6583190

    Patients

    Seq Age Sex Outcome Treatment
    1