BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.0MM TI HELICAL BLADE 95MM-STERILE

    MDR report key: 3070605 · Received April 22, 2013

    Report

    Report Number
    3003506883-2013-10130
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    June 6, 2012
    Report Date
    June 8, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. PLACEHOLDER.

    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 DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER DURING A TROCHANTERIC FIXATION NAIL (TFN) PROCEDURE, THE HELICAL BLADE WOULD NOT INSERT AND ADVANCE COMPLETELY. SURGEON REMOVED BLADE AND INSERTED A SHORTER BLADE, BUT ENDED UP HAVING TO FINISH ADVANCING THE BLADE BY HAND TO SEAT IT COMPLETELY. SURGEON SUGGESTED THE INSERTION HANDLE MAY BE BENT AND DISTORTED. INSERTION HANDLE IS AVAILABLE FOR RETURN. IT IS NOT KNOWN IF BLADE WILL BE RETURNED OR HAS BEEN DISCARDED BY THE HOSPITAL. TO DATE ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AND DOCUMENTED. THIS IS 1 OF 1 REPORT FOR EVENT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173156 11.0MM TI HELICAL BLADE 95MM-STERILE HSB SYNTHES ELMIRA 6867651

    Patients

    Seq Age Sex Outcome Treatment
    1