BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLOTTED-HAMMER 400G CAN BE MOUNTED

    MDR report key: 3132431 · Received May 29, 2013

    Report

    Report Number
    8030965-2013-02435
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    November 29, 2010
    Report Date
    February 16, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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: 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. THE HAMMER WAS RETURNED FOR INSPECTION BUT THE PIN WAS MISSING. THE RESULTS OF THE HOLE MEASURES OF THE HAMMERHEAD SHOW THAT POSSIBLE TOLERANCE PROBLEMS BETWEEN THE PIN AND THE HAMMER MAY HAVE CAUSE THIS MALFUNCTION. HOWEVER, AS THE PIN WAS NOT RETURNED, NO MEASUREMENTS COULD BE PERFORMED. THE INSTRUMENT WAS REPAIRED AND SENT BACK TO THE CUSTOMER. CONCLUSION: THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE AND NO PRODUCT FAULT COULD BE FOUND. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HAMMER WAS BROKEN AND THERE WAS A DEFECT IN THE CONNECTING PIN. NO FURTHER INFORMATION WAS PROVIDED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235144 SLOTTED-HAMMER 400G CAN BE MOUNTED FZY SYNTHES GMBH 1787701

    Patients

    Seq Age Sex Outcome Treatment
    1