BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI LAMINA HOOK-/ LEFT

    MDR report key: 3170613 · Received February 27, 2013

    Report

    Report Number
    2530088-2013-10561
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 25, 2010
    Report Date
    January 26, 2011
    Manufacturer
    SYNTHES BRADUWOME
    Product Code
    KWP
    PMA / PMN Number
    K091689
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    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. THE DEVICE HISTORY RECORD WAS REVIEWED AND REVEALED NO ISSUES RELATED TO THE COMPLAINT ISSUE. PRODUCT WAS RECEIVED BY INCOMING INSPECTION TO HAVE THE SCREWS COMPLETELY SEPARATED FROM THE DEVICE IN THE PACKAGE. THE PROTECTIVE COVER WAS VERIFIED TO BE IN INSTALLED OVER THE SET SCREW ASSEMBLY AT PACKAGING TO PREVENT THE SCREW FROM MIGRATING OUT DURING SHIPPING. THESE PARTS HAD BEEN SHIPPED TO (B)(4) WHERE THEY WERE REPACKAGED, THIS COMPLAINT IS INDETERMINATE. THE ORIGINAL LOT NUMBER IS 5849213, LOT NUMBER WAS CHANGED WHEN REPACKAGED AT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY (B)(4) INFORMED SYNTHES PRODUCT SERVICE, (B)(4), THAT MULTIPLE UNOPENED TRANSVERSE BARS (406.103) AND TRANSCONNECTORS (04.614.513 AND 04.614.514) WERE FOUND ON INCOMING INSPECTION TO HAVE THE SCREWS COMPLETELY SEPARATED FROM THE DEVICES INSIDE THE PACKAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85901 TI LAMINA HOOK-/ LEFT KWP SYNTHES BRADUWOME 3117326

    Patients

    Seq Age Sex Outcome Treatment
    1