BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM

    MDR report key: 3051350 · Received April 10, 2013

    Report

    Report Number
    1719045-2013-10562
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 7, 2012
    Report Date
    March 20, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    PMA / PMN Number
    K022012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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. THREAD OF SCREW REMAINS IMPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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. 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 A SURGICAL PROCEDURE THE SURGEON INFORMED THE O.R. STAFF THAT A SCREW BROKE DURING IMPLANTATION. THE THREAD OF THE SCREW WAS RETAINED IN THE PATIENT'S BONE FLAP. THE HEAD OF THE SCREW WAS RECOVERED AND PASSED OFF THE STERILE FIELD TO THE CIRCULATING NURSE, WHO BAGGED IT AND GAVE IT TO THE NEURO COORDINATOR. THE SURGEON STATED SHE WOULD NOT REMOVE THE IMPLANTED PORTION DUE TO DIFFICULTY. NO X-RAY WAS TAKEN AS BOTH PIECES WERE RECOVERED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153011 TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR