BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETAIN-SLEEVE LONG F/MATRIX 5.5

    MDR report key: 3202954 · Received July 2, 2013

    Report

    Report Number
    1719045-2013-01762
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 6, 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. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE DEVICE HISTORY REVIEW FOR THIS LOT HAS BEEN REQUESTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND NOT IMPLANTABLE. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND THE PARTS WERE MADE WITH THE CORRECT MATERIAL REQUIREMENTS, MET THE HARDNESS, AND MET REQUIRED SPECIFICATIONS. NO COMPLAINT RELATED ISSUES WERE FOUND. AN INVESTIGATION WAS CONDUCTED AND IT STATES THAT AT THE HOLDING SLEEVE THE THREAD WAS BROKEN. NO DEVIATION WAS RECOGNIZABLE DURING THE REVIEW OF THE MATERIAL AND MANUFACTURING DOCUMENTS. NO PRODUCT FAULT COULD BE DETECTED. NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, THE PLATE OF THE AWL BROKE OFF. IN ADDITION, THE THREAD OF THE RETAINING SLEEVE BROKE OFF. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301914 RETAIN-SLEEVE LONG F/MATRIX 5.5 LXH SYNTHES MONUMENT 6684422

    Patients

    Seq Age Sex Outcome Treatment
    1