BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM/3.0MM TI SELF-DRILLING SCHANZ SCREW 20MM THRD/80MM

    MDR report key: 3973778 · Received August 1, 2014

    Report

    Report Number
    2520274-2014-12965
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 3, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    KTT
    PMA / PMN Number
    PK122455
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). 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

    A MANUFACTURING EVALUATION WAS COMPLETED: AS THE EXACT LOT NUMBER IS NOT KNOWN THE PRESENT COMPLAINT CANNOT BE FULLY ANALYZED. DIMENSIONAL INSPECTION CANNOT BE PERFORMED DUE TO THE DAMAGE INCURRED. SINCE THE RELEVANT FEATURE CANNOT BE MEASURED ACCURATELY AND THE REVIEW OF THE MANUFACTURING DOCUMENTS CANNOT BE PERFORMED, THIS COMPLAINT IS JUDGED TO BE INDETERMINATE FROM A MANUFACTURING STANDPOINT.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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE INSTALLATION OF A DISTAL RADIUS DISTRACTOR, THE DOCTOR DESTROYED THE NAIL BECAUSE HE ALREADY PUT POWER ON THE PART BEFORE HE HAD PUSHED THE NAIL TOTALLY THROUGH THE CLAMP BEFORE TOUCHING THE BONE AND DRILLING IT INTO IT. THE DOCTOR FINISHED THE OPERATION WITH A NEW NAIL. THERE WAS NO PATIENT INFORMATION PROVIDED. THERE WAS HARM TO THE PATIENT. THERE WAS NO SURGICAL DELAY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450476 4.0MM/3.0MM TI SELF-DRILLING SCHANZ SCREW 20MM THRD/80MM APPLIANCE,FIXATION,NAIL KTT SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1