BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA LOCKSCR Ø2.4 SELF-TAP L18 TAN

    MDR report key: 3183177 · Received June 21, 2013

    Report

    Report Number
    8030965-2013-03762
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 15, 2012
    Report Date
    June 5, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    K102694
    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE EVALUATION REVEALED THAT THE LOCKING THREAD AT THE SCREW HEAD IS BADLY DEFORMED. THIS INDICATES CLEARLY MECHANICAL MISHANDLING DURING USE. WE HAVE TO ASSUME THAT TOO MUCH APPLIED MECHANICAL FORCE WHILE INSERTION MAY HAVE CAUSED THE DEFORMATIONS. REVIEWING THE MANUFACTURING AND MATERIAL DOCUMENTATION SHOWS CONFORMITY AS WELL. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SCREW HAS A TWISTED TIP. DURING INSERTION OF VA SCREWS TO PLATE BY HAND, THE SURGEON FIXED PLATE WITH AIMING BLOCK AND HE INSERTED SIX SCREWS INTO THE HOLES. HOWEVER HE COULD NOT FINISH LOCKING IN PROXIMAL ROW STYLOID HOLE. HE ADDITIONALLY INSERTED SCREW IN A HOLE, AND THIS SCREW WENT THROUGH THE PLATE. SO HE REMOVED THIS SCREW FROM FRACTURED PART OF THE PLATE AND FINISHED THE OPERATION. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283016 VA LOCKSCR Ø2.4 SELF-TAP L18 TAN HWC SYNTHES GMBH 7786288

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR