BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOLUCENT-DRIVE

    MDR report key: 3193369 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-03357
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    October 21, 2011
    Report Date
    December 5, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    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. (B)(6). A REVIEW OF THE DHR FOR THIS LOT HAS BEEN REQUESTED. TESTS HAVE NOT REVEALED ANY PROBLEM WITH THE INSTRUMENT IN QUESTION. THIS LED US TO BELIEVE THAT THE POSSIBILITY ARISES THAT THE DRILL BIT MAY HAVE BEEN BLUNT. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RADIOLUCENT DRIVE WAS USED FOR PROXIMAL SIDE LOCKING, BUT THE BONE COULD NOT BE CUT DUE TO THE TORQUE SHORTAGE. AFTER CHECKING AND TAKING OUT THE AIR, THE RADIOLUCENT DRIVE WAS REATTACHED AND RETIRED. WHEN THE DOCTOR ADDED THE PRESSING FORCE, THE LOWER AND REVERSE ROTATION GRADUALLY OCCURRED AND THE DRILL STOPPED, AS IF IT WAS RUNNING OUT OF BATTERY. THE SURGEON TRIED TO REDUCE THE SIZE DOWN TO 3.2MMM, THEN 2.7MM, BUT IT COULD NOT PENETRATE THE CORTICAL BONE AT THE OPPOSITE SIDE. IT MANAGED TO PIERCE THROUGH WITH USE OF THE NORMAL 4.0MM DRILL. AS THE DOCTOR PULLED ITS TRIGGER AFTER TAKING OUT THE DRILL FROM THE BONE, A CYLINDER OF THE RADIOLUCENT DRIVE HAPPENED TO ROTATE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293747 RADIOLUCENT-DRIVE HTW SYNTHES GMBH 10745

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR