BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELIX BLADE 85MM

    MDR report key: 4223051 · Received November 4, 2014

    Report

    Report Number
    2520274-2014-14473
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    KTT
    PMA / PMN Number
    PK042895
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    MANUFACTURING EVALUATION DETAILS, THE PART WAS RECEIVED AS ASSEMBLY, AND LAG SCREW SHAFT NOT ALIGNED WITH KEY. THE KEY SLOT IS DEFORMED. INSPECTED PART FOR RELATED NON-CONFORMANCES. LOT NUMBER IS NOT AVAILABLE, LOT NUMBER IS OBSCURED BY ASSEMBLY.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A DYNAMIC HELICAL HIP SYSTEM (DHHS), THE ADVANCING OF THE HELICAL BLADE JAMMED IN THE SIDE PLATE AND ADVANCED TOO FAR. THE HELICAL BLADE WAS STUCK SO IMPLANTS HAD TO BE REMOVED AND WAS REVISED WITH A DYNAMIC HIP SCREW (DHS). THERE WAS A TWENTY MINUTE SURGICAL DELAY. THE PATIENT STATUS/OUTCOME IS UNKNOWN. THIS REPORT IS 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708165 HELIX BLADE 85MM APPLIANCE, FIXATION, NAIL KTT SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR