BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKYLINE SPRING CLIP DRIVER

    MDR report key: 3153190 · Received June 8, 2013

    Report

    Report Number
    1526439-2013-18390
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    May 19, 2013
    Report Date
    May 21, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    HWR
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. DISCARDED BY CUSTOMER.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED DRIVER CONFIRMED THE TIP BREAKAGE. NO OTHER ABNORMALITIES WERE NOTED. A REVIEW OF THE DEVICE HISTORY RECORD ACKNOWLEDGED THAT NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE BEEN ATTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. A REVIEW OF THE COMPLAINT TREND ANALYSIS FOUND NO OBSERVED TRENDS FOR ISSUES OF THIS NATURE. ALTHOUGH, NO DEFINITIVE CONCLUSIONS CAN BE MADE, THE NOTED DAMAGE SUGGESTS THAT DRIVER UNDERWENT A CIRCUMSTANCE THAT RESULTED IN A HIGHER THAN ANTICIPATED TORQUE, CAUSING THE DISTAL TIP TO BREAK OFF. IN THE ABSENCE OF AN IDENTIFIED DEVICE MANUFACTURING/RELEASE ISSUE OR OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THE TIP OF THE SPRING CLIP DRIVER BROKE OFF FROM THE INSTRUMENT DURING PLACEMENT OF AN ANTERIOR CERVICAL PLATE. THE BROKEN TIP WAS RETRIEVED FROM THE SURGICAL SITE. HOWEVER, THE DIFFICULTY RESULTED IN A DELAY TO THE PROCEDURE OF APPROXIMATELY NINETY MINUTES WHILE ANOTHER DRIVER WAS LOCATED AND STERILIZED. CONCOMITANT DEVICE - SKYLINE ANTERIOR CERVICAL PLATE, CATALOG NUMBER UNKNOWN. SKYLINE SCREW, CATALOG NUMBER UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254854 SKYLINE SPRING CLIP DRIVER DRIVER, PROSTHESIS HWR DEPUY SYNTHES SPINE GM3403201

    Patients

    Seq Age Sex Outcome Treatment
    1