BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA LOCKSCR 2.4 SELF-TAP L20 TAN

    MDR report key: 3083438 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-11160
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    June 15, 2012
    Report Date
    June 29, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    K102694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED FOR EVALUATION.

    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 (A/RE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSERTION OF A VARIABLE ANGLE (VA) SCREWS, A SCREW WENT THROUGH THE HOLE OF THE PLATE. THE SURGEON PRE-FIXED THE VA SCREWS INTO THE HOLES AND FIXED THEM WITH A TORQUE LIMITING ATTACHMENT. HE WAS UNABLE TO SECURE THE SCREW INTO THE PROXIMAL ROW STYLOID HOLE. HE CONTINUED TO FIX THE SCREW AND IT WENT THROUGH THE HOLE. HE TRIED TO REMOVE THE SCREW, BUT IT WOULD NOT COME OUT. THEREFORE, HE FINISHED THE OPERATION. THE PLATE AND SCREW REMAIN IN THE PATIENTS BODY. THIS IS 2 OF 3 REPORTS FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185653 VA LOCKSCR 2.4 SELF-TAP L20 TAN HWC SYNTHES GMBH 7674306

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR