BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.0MM TI CRTX SCREW SLF-TPNG W/PLUSDRIVE(TM) RECESS 5MM

    MDR report key: 3061135 · Received April 16, 2013

    Report

    Report Number
    2520274-2013-11070
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    February 21, 2012
    Report Date
    March 20, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    K912932
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SURGEON WAS INSERTING SCREWS AND THE HEADS BROKE OFF OF SIX 1.0MM CORTEX SCREWS. ALL BROKEN PIECES WERE RETRIEVED. THERE WERE ENOUGH BACK-UP SCREWS AND THE PROCEDURE WAS COMPLETED WITHOUT ANY HARM TO THE PATIENT. THE BROKEN SCREWS WERE DISCARDED. COMPLAINT #5 OF 6. (5TH SCREW OF 6 SCREWS).

    Description of Event or Problem · 1

    THIS IS REPORT 5 OF 6 FOR THIS COMPLAINT (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163418 1.0MM TI CRTX SCREW SLF-TPNG W/PLUSDRIVE(TM) RECESS 5MM HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1