BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETAIN-SLEEVE LONG F/MATRIX 5.5

    MDR report key: 3102115 · Received May 9, 2013

    Report

    Report Number
    1719045-2013-01418
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 15, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE DEVICE HISTORY RECORD REVIEW FOR THIS LOT HAS BEEN REQUESTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. MAGNUM MANUFACTURING CENTER MANUFACTURED THE HOLDING SLEEVE ¿ LONG FOR MATRIX, PART 03.632.036, AND LOT NUMBER 6508192. THE SUPPLIERS CERTIFICATE OF COMPLIANCE, DATED MARCH 4, 2011, INDICATES THE PARTS WERE MANUFACTURED TO PART 03.632.036, REVISION G AND MET THE REQUIRED SPECIFICATIONS. THE LOT WAS INSPECTED AND CONFORMED TO THE SYNTHES, TABULATED INCOMING FINAL INSPECTION SHEET NUMBER (B)(4), REVISION L, DATED MARCH 7, 2011. THERE WERE NO NON CONFORMITIES OR OTHER COMPLAINT RELATED ISSUES ASSOCIATED WITH THIS COMPLAINT. DUE TO AN UNKNOWN CAUSE, THE THREADED TIP BROKE. THE MATERIAL AND HARDNESS OF THE INNER SLEEVE WAS CONFIRMED TO BE WITHIN SPECIFICATION AND THE DIAMETER NEAR THE TIP PASSED SPECIFICATIONS. THE THREADS, THREADED TIP DEPTH AND LOCATION WERE UNABLE TO BE VERIFIED DUE TO THE DAMAGE ON THE TIP. THE PARTS ALL PASSED INSPECTION AT THE TIME OF MANUFACTURING.

    Description of Event or Problem · 1

    ON AN UNKNOWN DATE, IT WAS DISCOVERED THAT A SCREW HAD THE THREAD BROKEN OFF AT THE DISTAL END. IT IS UNKNOWN WHERE THIS OCCURRED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202765 RETAIN-SLEEVE LONG F/MATRIX 5.5 LXH SYNTHES MONUMENT 6508192

    Patients

    Seq Age Sex Outcome Treatment
    1