BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCR Ø1.5 SELF-TAP L6 TAN 4U I/CLIP

    MDR report key: 3180724 · Received June 20, 2013

    Report

    Report Number
    8030965-2013-03154
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    August 6, 2012
    Report Date
    August 10, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    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 ADDITIONAL EVALUATION REVEALED THAT THE SCREW HEAD IS DAMAGED. THE FRAGMENT SHOWS THAT THE UPPER PART IS BROKEN OFF DUE TO EXCEEDING APPLIED TORSIONAL FORCE WHILE USE. THE COMPLETE SCREW SHOWS SIGNS OF STRONG MECHANICAL IMPACT BY THE USER. THE UPPER PART WAS OVER TORQUE. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ONE SCREW IS DAMAGED. THE CONCERNED PRODUCT WAS BEING USED IN THE PROCEDURE OF THE ZYGOMATIC FRACTURE. A BOX PLATE WAS USED TO BE FIXED TO THE INFRA-ORBITAL BORDER BY FOUR SCREWS. ONE OUT OF THE FOUR SCREWS IS THE CONCERNED SCREW. THE CROSS RECESS OF THE SCREW HEAD LOCKED WHEN INSERTING THE SCREW. SO THE SCREW COULD NOT BE USED, THE DOCTOR USED A SUBSTITUTE FOR IT. ALL THE SCREWS WERE FIXED IN A SAME PROCEDURE, AND ONLY THIS SCREW WAS DAMAGED. WHEN A DOCTOR INSERTED IT INTO THE INFRA-ORBITAL BORDER, HE HAD A SENSE THAT ONLY THIS SCREW WAS FRAGILE, AND THOUGH OTHER SCREWS WERE NORMAL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280850 SCR Ø1.5 SELF-TAP L6 TAN 4U I/CLIP HWC SYNTHES GMBH 7867746

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR