BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER SHAFT T8105MM

    MDR report key: 3083447 · Received April 29, 2013

    Report

    Report Number
    1719045-2013-10906
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    June 8, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THIS PRODUCT WAS MANUFACTURED IN ACCORDANCE TO ALL DRAWING REQUIRMENTS. THEREFORE THIS COMPLAINT IS INVALID FROM A MANUFACTURING STANDPOINT. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED THAT THE PRODUCT RETURNED IN ONE PIECE WITH ALL GEOMETRY PRESENT BUT IN USED, NOT AS NEW CONDITION. COSMETICALLY THERE IS SURFACE STAINING PRESENT ABOUT THE SHAFT. PRODUCT WAS RETURNED WITH DEFORMED SPLINE FEATURES OF THE STARDRIVE GEOMETRY. OWING TO THE CONDITION OF THE DAMAGED SPLINES OF THE STARDRIVE AND THE INABILITY TO OBTAIN RELIABLE MEASUREMENTS, THE FINIDING FOR THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORIF WRIST PROCEDURE A T8 SCREWDRIVER TIP BROKE OFF. ALL PIECES WERE RETRIEVED AND THERE WAS NO HARM TO PATIENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185656 STARDRIVE SCREWDRIVER SHAFT T8105MM HXX SYNTHES MONUMENT 6612911

    Patients

    Seq Age Sex Outcome Treatment
    1