BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAMP RADIOLUC

    MDR report key: 3192535 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-04123
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 21, 2012
    Report Date
    June 24, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE EVALUATION REVEALED THAT THE NUT WAS ASSEMBLED THE WRONG WAY AND RESULTED ON THE CLAMP TO BE CLAMPED AND JAMMED TOGETHER. UNFORTUNATELY WE COULD NOT GET ANY ADDITIONAL INFORMATION TO THIS COMPLAINT FROM THE SUPPLIER. HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. AN INTERNAL CORRECTIVE ACTION DETERMINATION HAS BEEN OPENED TO ADDRESS THIS ISSUE. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A FRACTURE OF THE DISTAL RADIUS AND ONE OF THE CLAMPS FROM THE SMALL EXTERNAL FIXATION SYSTEM DID NOT WORK. THE SMALL EXTERNAL FIXATION RADIOLUCENT WAS USED FOR THE FRACTURE SURGERY ON (B)(6) 2012. THE DOCTOR HAD DIFFICULTY WITH THREE OF THE SIX POLYMER CLAMPS AND ONE CLAMP DID NOT WORK AT ALL. THE SYNTHES SALES REPRESENTATIVE DID NOT ATTEND THE OPERATION, SO THE HOSPITAL CALLED HIM DURING THE OPERATION. THE CONSULTANT BROUGHT ANOTHER SMALL EXTERNAL FIXATION RADIOLUCENT, AND ONE CLAMP WAS FROM THAT SET WAS USED TO FINISH THE OPERATION WITHOUT FURTHER PROBLEMS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292251 CLAMP RADIOLUC KTT SYNTHES GMBH 0010413

    Patients

    Seq Age Sex Outcome Treatment
    1