BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 3.5MM CORTEX SCREWS

    MDR report key: 3041872 · Received April 8, 2013

    Report

    Report Number
    2530088-2013-10367
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Report Date
    March 26, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HTJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 DHR WAS REVIEWED AND NO NONCONFORMANCES RELATED TO THIS COMPLAINT WERE FOUND. 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 A DEPTH GAUGE SEEMS TO TRAP FLUID BEHIND THE DETENTE BALL ON THE CALIBRATION PIECE. THIS DEPTH GAUGE IS USED FOR VARIOUS PROCEDURES BUT SEEMS TO HAPPEN MOST FREQUENTLY WITH TIBIA NAIL CASES. THE NATURE OF THE FLUID RANGES FROM GREASY AND SLIMY TO CLEAR. WHEN THE DETENTE BALL IS DEPRESSED, FLUIDS CAN ENTER THE CAVITY BEHIND THE BALL AND THEN THE BALL ACTS LIKE A SEALED VALVE WHEN RELEASED. THE FLUID THEN LEAKS OUT WHEN THE OUTER SLEEVE IS THEN PLACED BACK ON THE CALIBRATED PIECE. IT ALLOWS THE BALL TO BE DEPRESSED AND RELEASES ANY TRAPPED FLUIDS WITHIN THE BALL SITE. THE HOSPITAL STATED THAT THE DEPTH GAUGE IS CLEANED PROPERLY AFTER EACH USE INCLUDING HAND WASHING, SONIC WASHING AND STERILIZATION.

    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
    143944 DEPTH GAUGE FOR 3.5MM CORTEX SCREWS HTJ SYNTHES BRANDYWINE 6034505

    Patients

    Seq Age Sex Outcome Treatment
    1