BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VECTRA-PL 4/4.5 2 SEGMENTS L43 TAN BLUE

    MDR report key: 3180698 · Received June 20, 2013

    Report

    Report Number
    8030965-2013-03693
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    KWQ
    PMA / PMN Number
    K033844
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 ONE MIDDLE CLIP OF THE PLATE IS INDEED BADLY BENT AND CAME OUT OF ITS POSITION. UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE WHICH HAS LEAD TO THIS DEFORMATION. WE CAN ONLY SUPPOSE THAT THERE WAS A PROBLEM DURING THE INSERTION OF THE SCREW AND CAUSED THE CLIP TO POP OUT. PLEASE NOTE THAT WE HAVE NOT HAD A SINGLE COMPLAINT WITH THIS ITEM SO FAR. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLATE HAD BEEN ROTATED AND BENT OUT OF SHAPE. THE SURGEON WAS USING THE DRILL AND SCREW GUIDE TO INSERT A SCREW INTO THE PLATE. WHEN HE WAS SCREWING IN THE SCREW HE SAID HE FELT SOME UNUSUAL RESISTANCE. THE SCREW WAS NOT SITTING CORRECTLY, SO HE REMOVED THE SCREW USING THE REMOVAL DEVICE. ON A CLOSER LOOK AT THE PLATE, IT APPEARED THAT THE ELGINOY CLIP HAD BEEN ROTATED AND BENT OUT OF SHAPE. THROUGHOUT THE PROCEDURE, THE SURGEON WAS USING THE CORRECT TECHNIQUE. THE SURGEON IS EXPERIENCED WITH THE VECTRA INSTRUMENT. HE REMOVED THE PLATE AND PUT IN A NEW ONE WITHOUT ANY ISSUES. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279900 VECTRA-PL 4/4.5 2 SEGMENTS L43 TAN BLUE KWQ SYNTHES GMBH 3810211

    Patients

    Seq Age Sex Outcome Treatment
    1