BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDER F/SET F/BONEGRAFT-HARVEST INCL NO

    MDR report key: 3183121 · Received June 21, 2013

    Report

    Report Number
    8030965-2013-03465
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    December 5, 2011
    Report Date
    December 7, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 EVALUATION REVEALED THAT ONE OF THREE PRONGS IS INDEED BROKEN OFF. WE ACKNOWLEDGE THAT THIS IS A RATHER DELICATE DESIGN BUT WE SUPPOSE THAT SIMPLY TOO MUCH MECHANICAL FORCE WAS APPLIED AND CAUSED THE BREAKAGE. PLEASE KEEP IN MIND THAT THE FORCE FROM THE HANDLE TO THE TIP IS ENORMOUS. NO PRODUCT FAULT COULD BE DETECTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE OF THE THREE PRONGS AT THE TIP OF THE HOLDER FOR BONE GRAFT HARVESTING SET (387.657) HAS BROKEN OFF. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283784 HOLDER F/SET F/BONEGRAFT-HARVEST INCL NO LXH SYNTHES GMBH 2122299

    Patients

    Seq Age Sex Outcome Treatment
    1