BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTER F/TEN

    MDR report key: 3212875 · Received July 9, 2013

    Report

    Report Number
    8030965-2013-04258
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Report Date
    June 11, 2013
    Manufacturer
    SYNTHES GMBH
    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. ADDITIONAL NARRATIVE: THE ADDITIONAL EVALUATION REPORTS AS RECEIVED CONDITION TO BE MECHANISM JAMS AND DOES NOT WORK. THE REPORT STATES THAT THE INVESTIGATION HAS SHOWN THE MECHANISM OF THE COUPLING PART IS INDEED BLOCKED. THEREFORE, IT IS NOT POSSIBLE TO ENGAGE THE SCREWDRIVER SHAFT ANY LONGER. THE FACT IS KNOWN THAT HIGH MECHANICAL FORCE WILL BE APPLIED TO THE SCREWDRIVER DURING USE. IT IS ESPECIALLY TAKEN INTO CONSIDERATION WHILE LOCKING SCREWS AND PLATES THAT THIS MECHANISM IS LIMITED TO ITS FUNCTION. IN ADDITION, DUE TO THE MARKET FEEDBACK AND IN TERMS OF CONTINUAL IMPROVEMENTS THIS INSTRUMENT WAS SUBJECTED TO FURTHER ANALYSIS. WE ARE GLAD TO INFORM THAT THE ENHANCED DESIGN IS ALREADY AVAILABLE. THIS INSTRUMENT HAS UNDERGONE CONTINUAL IMPROVEMENTS AND IS NOW IN AN ENHANCED DESIGN.

    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. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE WELD OF THE HANDLE OF THE TITANIUM ELASTIC NAIL (TEN) INSERTER BROKE INSIDE THE HANDLE ON AN UNKNOWN DATE. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313489 INSERTER F/TEN LXH SYNTHES GMBH 8012353

    Patients

    Seq Age Sex Outcome Treatment
    1