BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOCKET-HEX Ø4/11 CANN F/AFN

    MDR report key: 3132402 · Received May 29, 2013

    Report

    Report Number
    8030965-2013-02429
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    February 2, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. ADDITIONAL INFORMATION. ACTUAL EVENT DATE NOT KNOWN. 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. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON CONFORMANCES AND WE CAN ONLY ASSUME THAT HIGH APPLIED MECHANICAL FORCES CAUSED THE BREAKAGE. CONCLUSION: THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE AND THE COMPLAINT CONDITION IS DUE TO AN UNKNOWN CAUSE. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP BROKE OFF. NO FURTHER INFORMATION WAS PROVIDED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234963 SOCKET-HEX Ø4/11 CANN F/AFN HXX SYNTHES GMBH 24611

    Patients

    Seq Age Sex Outcome Treatment
    1