BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPT F/BLADE F/REMOVAL OF PFNA-BLADES

    MDR report key: 3183594 · Received June 22, 2013

    Report

    Report Number
    8030965-2013-03340
    Event Type
    Malfunction
    Date Received
    June 22, 2013
    Report Date
    March 23, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    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 THREAD-TIP WAS BROKEN OFF AND GOT DETACHED FROM THE ADAPTER. WE SUPPOSE THAT A MECHANICAL OVERLOAD SITUATION HAS LED TO THIS DAMAGE. FURTHER INVESTIGATION SHOWED CONFORMITY OF THE ARTICLE IN QUESTION TO THE COMPANY SPECIFICATION AND NO APPARENT FAULT OF MATERIAL OR MANUFACTURING WAS 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 ADAPTER WITH THREAD BROKE DURING TESTING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284408 ADAPT F/BLADE F/REMOVAL OF PFNA-BLADES HWE SYNTHES GMBH 7514229

    Patients

    Seq Age Sex Outcome Treatment
    1