BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTILOC HN Ø8.5 R CANN L255 TAN

    MDR report key: 3161329 · Received June 11, 2013

    Report

    Report Number
    8030965-2013-02863
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    June 5, 2012
    Report Date
    June 6, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    PMA / PMN Number
    K120807
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    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 NAIL IS SLIGHTLY MOVING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NAIL IS SLIGHTLY MOVING. MISSED NAIL PROXIMAL OVER GUIDING DEVICE DUE TO TOO MUCH CLEARANCE OF THE NUTCH (SIC) ON THE NAIL. INSERTION ARM ROTATED AFTER SECURING THE CONNECTION SCREW WITH WRENCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263298 MULTILOC HN Ø8.5 R CANN L255 TAN HSB SYNTHES GMBH 5916075

    Patients

    Seq Age Sex Outcome Treatment
    1