BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12MM/130 DEG TI CANN TROCH FIXATION NAIL 235MM-STERILE

    MDR report key: 3081561 · Received April 29, 2013

    Report

    Report Number
    1719045-2013-10875
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    November 1, 2012
    Report Date
    November 1, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Removal / Correction Number
    154
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    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. A REVIEW OF DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. ACCORDING TO THE PRODUCT DEVELOPMENT EVENT EVALUATION, THE CUSTOMER REPROCESSED 8 NAILS IN WHICH ALL THE END CAPS MELTED. THE REVISION F OF THE PRODUCT INSERT CONTAINS THE FOLLOWING NOTE: THE PACKAGING, INCLUDING PLASTIC END CAPS, MUST BE DISCARDED PRIOR TO STERILIZATION OF THE DEVICE. ONLY 1 OF THE 30 NAILS ASSOCIATED WITH THIS COMPLAINT CONTAINED THE REVISION F OF THE INSERT. THE PREVIOUS VERSIONS DID NOT CONTAIN THE NOTE DESCRIBED ABOVE. THE REVISION F OF THE PRODUCT INSERT WAS RELEASED AND IMPLEMENTED IN (B)(6) 2012. ONLY 1 OF THE 30 NAILS CONTAINED THE LATEST VERSION OF THE PRODUCT INSERT. THE CUSTOMER DID NOT CHECK ALL PRODUCT INSERTS, AND SELECTED A PREVIOUS REVISION OF THE INSERT WHICH DID NOT CONTAIN THE NOTE TO REMOVE ALL PACKAGING. THE CURRENT REVISION OF THE PRODUCT INSERT IS ALREADY UP TO DATE WITH THE APPROPRIATE INFORMATION, SO NO FURTHER CHANGES ARE NEEDED. THE UPDATED REVISION OF THE PRODUCT INSERT AND AN FAQ CONTAINING THE INSTRUCTIONS TO REMOVE THE PLASTIC END CAP WAS SENT OUT TO ALL SALES CONSULTANTS ON NOVEMBER 1, 2012 AS PART OF THE NAIL RECALL COMMUNICATIONS TO INSURE THAT THEY HAD THE MOST UP TO DATE INFORMATION TO RELAY TO THEIR CUSTOMERS. BOTH OF THESE ITEMS WERE ALSO MADE AVAILABLE ON THE SYNTHES TRAUMA NAIL RECALL PORTAL PAGE IN NOVEMBER.

    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.(B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE AFFECTED NAILS WERE STERILIZED IN RESPONSE TO SYNTHES IM NAIL RECALL. THE SALES CONSULTANT INSTRUCTED THE FACILITY TO FOLLOW THE STERILIZATION INSTRUCTIONS ENCLOSED IN THE TFN PACKAGING. THE PARTICULAR NAIL PACKAGING THAT WAS USED AS THE REFERENCE, DID NOT INCLUDE THE INSTRUCTIONS TO REMOVE THE PLASTIC CAP. THE RESULT WAS THAT ALL 30 OF THE FACILITY NAILS WERE PROCESSED IN THIS MANNER WITH A PLASTIC CAP IN PLACE WHICH SUBSEQUENTLY MELTED. THIS IS 8 OF 30 REPORTS FOR EVENT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184830 12MM/130 DEG TI CANN TROCH FIXATION NAIL 235MM-STERILE HSB SYNTHES MONUMENT 7008760

    Patients

    Seq Age Sex Outcome Treatment
    1