BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THREADED DRILL GUIDE

    MDR report key: 3073087 · Received April 23, 2013

    Report

    Report Number
    1719045-2013-10815
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    June 11, 2012
    Report Date
    June 11, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    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. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.

    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).

    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.SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS.(B)(4)

    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 MANUFACTURING EVALUATION WAS PERFORMED ON THE RETURNED PRODUCT AND CONFIRMED THAT THE CLIPS ARE BENT/BROKEN AS REPORTED. INSPECTION RECORDS WERE REVIEWED AND INDICATED THE PRODUCT WAS WITHIN SPECIFICATION AT THE TIME OF MANUFACTURE. COMPLAINT WAS DEEMED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE.

    Description of Event or Problem · 1

    CONSULTANT REPORTED DURING ALIF PROCEDURE (L5-S1) TWO INTERNAL DRILL GUIDES WHERE THEY CONNECT TO THE HOLDER WERE DAMAGED. ON ONE DRILL GUIDE, THE SMALL CLIP BROKE AND ON THE OTHER DRILL GUIDE, THE SMALL CLIP BENT. NO HARM TO PATIENT, SURGEON COMPLETED PROCEDURE USING OTHER INSTRUMENTS IN THE SET. THIS IS 1 OF 1 REPORT FOR EVENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173215 THREADED DRILL GUIDE FZX SYNTHES MONUMENT 002724

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR