BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA LOCKSCR Ø2.4 SELF-TAP L18 TAN

    MDR report key: 3183073 · Received June 21, 2013

    Report

    Report Number
    8030965-2013-03337
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    August 15, 2012
    Report Date
    August 21, 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 ADDITIONAL EVALUATION REVEALED THAT THE SCREW WAS PRESSED UNDER HIGH PRESSURE THROUGH THE HOLE OF THE PLATE. THE HEAD OF THE SCREW IS BADLY DEFORMED WHAT INDICATES HEAVY APPLIED MECHANICAL FORCE WHILE INSERTING. THE MEASURABLE DIMENSIONS OF THE DEVICES WERE CHECKED AND ALL ARE WITHIN SPECIFICATION. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSERTION OF VA SCREWS TO PLATE BY HAND THE SCREW WENT THROUGH THE HOLE. THE SURGEON USED GUIDING BLOCK, DRILL SLEEVE AND TLA. HE STARTED INSERTING FROM DISTAL TO PROXIMAL SIDE BY FIXATION-MODE (HE INSERTED WITH PRESS IN DISTAL SIDE). WHEN HE INSERTED THE VA SCREW IN SECOND DISTAL STYLOID SIDE, HE COULD NOT FEEL LOCKING. WHEN HE CONFIRMED INSERTION OF THE SCREW, HE FOUND THAT VA SCREW WENT THROUGH IN THIS HOLE. INSERTING SCREW AND PLATE HOLES WERE NOT DAMAGED. THE SCREW COULD BE REMOVED AND IT IS BELIEVE THAT IT WAS DAMAGED DURING REMOVAL. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4). THIS REPORT IS ON THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283301 VA LOCKSCR Ø2.4 SELF-TAP L18 TAN HWC SYNTHES GMBH 7933247

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR