BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORACIC PEDICLE PROBE

    MDR report key: 3062478 · Received April 17, 2013

    Report

    Report Number
    1719045-2013-10708
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    December 13, 2011
    Report Date
    December 13, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. THE DEVICE WAS MANUFACTURED BY TELEFLEX MEDICAL. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RETURNED FOR A MANUFACTURING EVALUATION AND THE SHAFT ON THE PROBE WAS BENT. THE SHAFT OF THIS DEVICE MAY BEND OR BREAK IF EXCESSIVE FORCE OR SIDE PRESSURE IS APPLIED. THE MATERIAL USED IN THE MANUFACTURE OF THIS PART AND THE HARDNESS OF THE MATERIAL WERE WITHIN THE SPECIFIED REQUIREMENTS. THE EVALUATION PERFORMED BY TELEFLEX INDICATED THAT THE REPORTED FAILURE IS NOT ASSOCIATED WITH THE MANUFACTURING PROCESSES AND IS DUE TO AN UNKNOWN CAUSE. THEREFORE, THIS COMPLAINT IS INVALID FROM A MANUFACTURING STANDPOINT.

    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 A LUMBAR L5-S1 FUSION PROCEDURE, THE SURGEON WAS USING A THORACIC PEDICLE PROBE TO PUSH INTO THE PEDICLE TO PLACE THE SCREW WHEN THE PROBE BENT. THE CONSULTANT TRIED BENDING THE PROBE BACK AND IT BROKE. NOTHING BROKE INTO WOUND AND THE PIECES WERE RETRIEVED. THE SURGEON WAS ABLE TO USE ANOTHER PROBE AND RATCHET HANDLE TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS AND NO HARM TO THE PATIENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166175 THORACIC PEDICLE PROBE HXX SYNTHES MONUMENT 6667767

    Patients

    Seq Age Sex Outcome Treatment
    1