BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.25MM KIRSCHNER WIRE W/TROCAR POINT 150MM

    MDR report key: 3081207 · Received April 26, 2013

    Report

    Report Number
    3003506883-2013-10144
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    August 15, 2012
    Report Date
    August 15, 2012
    Manufacturer
    SYNTHES
    Product Code
    LRN
    PMA / PMN Number
    PRE-AM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE MANUFACTURING EVALUATION SHOWED THE RELEVANT DIMENSIONS OF THE AFFECT HOLE AND THE K-WIRE CANNOT BE VERIFIED ANYMORE AS THE WIRE FRAGMENT IS STUCK IN THE HOLE. THEREFORE THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT. ALL OTHER K-WIRE HOLES OF THIS PLATE WERE CHECKED AND FOUND WITHIN THE SPECIFICATION. AT THE UPPER SIDE OF THE PLATE IS AT THE EDGE OF THE HOLE WITH THE WIRE A DAMAGE OF THE SURFACE VISIBLE. THIS DAMAGE WAS CAUSED POST-MANUFACTURING AS THE ANODIZATION LAYER IS WORN AWAY. BUT AFTERWARDS IT CANNOT BE DEFINED IF THIS DAMAGE, WHICH COULD HAVE CAUSED A DEFORMATION OF THE HOLE, WAS CAUSED DURING THE WIRE INSERTION OR DURING CUTTING OF THE WIRE AFTER IT WAS STUCK. ADDITIONAL PRODUCT CODES FOR THIS REPORT INCLUDE HTY.

    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. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DISTAL RADIUS FX, THE SURGEON IMPLANTED THE PLATE WITH THE K-WIRE PROVISIONALLY FIXATING THE HARDWARE. WHEN THE SURGEON ATTEMPTED TO REMOVE THE K-WIRE, HE WAS UNABLE TO DO SO. THERE WAS APPROXIMATELY 15 MINS ADDED TO THE PROCEDURE. THE SURGEON THEN REMOVED ALL THE HARDWARE AND IMPLANTED A NEW PLATE WITH SCREWS WITHOUT FURTHER INCIDENT AND NO ADVERSE EVENT TO THE PATIENT. THIS REPORT IS 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182802 1.25MM KIRSCHNER WIRE W/TROCAR POINT 150MM LRN SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1