BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM CANNULATED SCREW FULLY THREADED/56MM

    MDR report key: 3072415 · Received April 23, 2013

    Report

    Report Number
    1719045-2013-10733
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    June 22, 2012
    Report Date
    June 22, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K963172
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 RETURNED SCREW IS BROKEN MID SHAFT. THE HEADED PORTION WITH A FEW THREADS WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION IS CONSISTENT WITH PRODUCT COMPLAINT. THE CANNULATION, HEAD PROFILE, THREAD MAJOR DIAMETER AND THREAD MINOR COULD NOT BE ACCURATELY MEASURED. ALTHOUGH THERE ARE THREADS PRESENT THERE ARE NOT ENOUGH REMAINING THREADS TO MEASURE WITH CONFIDENCE. SINCE ALL THE RELEVANT FEATURES COULD NOT BE CHECKED DUE TO DAMAGE AND NO LOT NUMBER WAS PROVIDED THIS COMPLAINT IS INDETERMINATE 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. 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 ANKLE FRACTURE PROCEDURE, SURGEON WAS INSERTING THE SCREWS INTO THE ANKLE AND THE SCREWS BROKE BELOW THE SCREW HEAD. THE BROKEN SCREW HEADS WERE RETRIEVED. THE SCREW SHAFTS REMAINS IN THE PATIENTS ANKLE BONE. SURGEON COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEMS. NO ADVERSE EFFECT TO THE PATIENT. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175023 4.5MM CANNULATED SCREW FULLY THREADED/56MM HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1