BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKSCR Ø3.5 SELF-TAP L10 TAN

    MDR report key: 3132570 · Received May 29, 2013

    Report

    Report Number
    8030965-2013-02409
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    December 20, 2012
    Report Date
    February 28, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K000684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    AN ADDITIONAL EVALUATION WAS PERFORMED AND THE REPORT STATED THE FOLLOWING: THE COMPLAINED DEVICE WAS FORWARDED TO THE MANUFACTURING PLANT FOR INVESTIGATION. THE INVESTIGATION CONFIRMED THE SCREW (CATALOG NUMBER 413.020S) WAS PACKAGED AND MISLABELED, AS THE LABELING WAS FOR ANOTHER SCREW (CATALOG NUMBER 413.010S). FURTHER, IT WAS ALSO DETERMINED THE SCREW (CATALOG NUMBER 413.010S) WAS PACKAGED WITH THE WRONG LABEL, AS IT STATED THIS WAS A SCREW WITH CATALOG NUMBER 413.020S. THE INVESTIGATION SHOWED THAT THE FAILURES OCCURRED DURING THE PACKAGING PROCESS. IT WAS ALSO REPORTED A CORRECTIVE ACTION AND PREVENTIVE ACTION (CAPA) INVESTIGATION HAS BEEN INITIATED BY THE SUPPLIER OF SCREWS. REPORTED INCORRECTLY AS NOT SOLD IN U.S. PRODUCT IS MARKETED AND SOLD IN THE U.S. THE 510(K) NUMBER IS K000684. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT IS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2012, DOCTOR SELECTED A LOCKSCR 3.5 SELFTAP L20 TAN. WHEN THE NURSE BROKE THE SEAL OF THE STERILIZED PACKAGE, IT WAS DISCOVERED THAT THE ACTUAL SCREW IN THE PACKAGE WAS A LOCKSCR 3.5 SELFTAP L10 TAN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS FOR A LOCKSCR 3.5MM SELF-TAP L10 TAN. THIS IS 2 OF 2 DEVICES FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THIS IS 2 OF 2 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236380 LOCKSCR Ø3.5 SELF-TAP L10 TAN KTT SYNTHES GMBH 2747402

    Patients

    Seq Age Sex Outcome Treatment
    1