BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING SLEEVE-LONG FOR MATRIX

    MDR report key: 3031049 · Received April 2, 2013

    Report

    Report Number
    1719045-2013-00837
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    February 1, 2013
    Report Date
    March 4, 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

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE INVESTIGATION HAS SHOWN THAT THE TIP OF THE THREAD IS BROKEN OFF AS COMPLAINED. THE REVIEW OF THE PRODUCTION HISTORY REVEALED THAT THIS INSTRUMENT WAS MANUFACTURED IN JANUARY 2011 ACCORDING TO THE SPECIFICATIONS. BASED ON THE VISUAL INSPECTION WE HAVE TO ASSUME THAT THE RETAINING SLEEVE WAS NOT TIGHTENED PROPERLY IN THE PRIMELOCK THREAD. SUCH A LOOSE CONNECTION, IN COMBINATION WITH HIGH LATERAL STRESS, INCREASED SOFT TISSUE PRESSURE, AND CORRECTION OF THE SCREW COURSE CAN LEAD TO AN OVERLOAD SITUATION AND FINALLY TO THE BREAKAGE OF THE TIP OF THE RETAINING SLEEVE. THE DEVICE WENT TO THE MANUFACTURING FACILITY FOR EVALUATION: MAGNUM MANUFACTURING CENTER MANUFACTURED THE RETAINING SLEEVE ¿ LONG FOR MATRIX, PART 03.632.036, LOT 6455791. DUE TO AN UNKNOWN CAUSE, PART OF THE THREADED TIP BROKE OFF. THE PART CONFORMED TO ALL DIMENSIONAL AND MATERIAL SPECIFICATIONS AT THE TIME OF MANUFACTURING. THE PERTINENT MATERIAL SPECIFICATIONS AND HARDNESS VALUES HAVE BEEN CONFIRMED. THE THREADS AND INNER DIAMETER OF THE INNER SLEEVE WERE CONFIRMED TO BE WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DEVICE WAS RECEIVED AND IS ENTERING THE COMPLAINT SYSTEM. THE DATE OF MANUFACTURE FOR THE DHR HAS BEEN REPORTED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: THE THREADED TIP OF THE HOLDING SLEEVE BROKE OFF. DURING SCREW INSERTION THE TIP OF THE INSTRUMENT BROKE OFF. NO INSTRUMENT MATERIAL WAS LEFT IN PATIENT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134005 HOLDING SLEEVE-LONG FOR MATRIX LXH SYNTHES MONUMENT 6455791

    Patients

    Seq Age Sex Outcome Treatment
    1