BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETAIN-SLEEVE LONG F/MATRIX 5.5

    MDR report key: 3160793 · Received June 11, 2013

    Report

    Report Number
    1719045-2013-01597
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    November 14, 2011
    Report Date
    February 15, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. THE INVESTIGATION OF THE COMPLAINED RETAINING SLEEVE SHOWS THAT A PART OF PITCH OF THE THREAD BROKE OFF. WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE. AT THIS POINT WE CAN ONLY ASSUME THAT A SHORT MECHANICAL OVERLOAD CAUSED THIS DAMAGE, THIS WOULD EXPLAIN THE CLEARLY VISIBLE STRESS MARKS AT THE SHAFT. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. FURTHER INVESTIGATION SHOWED CONFORMITY OF THE ARTICLE IN QUESTION TO THE COMPANY SPECIFICATION AND NO APPARENT FAULT OF MATERIAL OR MANUFACTURING WAS DETECTED. CONCLUSION ¿ THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. THE EXACT REASON FOR THIS OCCURRENCE UNFORTUNATELY REMAINS UNKNOWN AND WITHOUT ADDITIONAL INFORMATION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THE DEVICE FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MATRIX SLEEVE BROKE DURING SURGERY. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262846 RETAIN-SLEEVE LONG F/MATRIX 5.5 LXH SYNTHES MONUMENT 6489807

    Patients

    Seq Age Sex Outcome Treatment
    1