BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM VA LOCKING SCREW STARDRIVE 22MM

    MDR report key: 3083446 · Received April 29, 2013

    Report

    Report Number
    1719045-2013-10941
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    June 14, 2012
    Report Date
    June 14, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    K102694
    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. 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)

    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. ONE SCREW WAS RECEIVED WITH THE TASK ASSOCIATED WITH THIS COMPLAINT. THE SCREW IS WHOLE AND IS IN FAIR CONDITION, OVERALL. THE LENGTH IS 22.43MM AND THE DIAMETER IS 2.35MM AND THIS IS CONSISTENT WITH SPECIFICATIONS. THE DRIVE HAS BEEN DAMAGED IN THE FORM OF DISPLACED MATERIAL AT THE TOP OF THE HEAD. THE COLORING AT THE TOP OF THE HEAD HAS NEARLY BEEN ERADICATED. THE HEAD THREADS HAVE IMPACT MARKS/DISPLACED MATERIAL. THE SHAFT THREADS HAVE ALSO BEEN DAMAGED. BECAUSE OF THE TYPE AND EXTENT OF THE DAMAGE INCURRED, AND ALSO BECAUSE NO LOT NUMBER WAS PROVIDED, A FINITE EVALUATION IS NOT POSSIBLE. THEREFORE, THIS COMPLAINT IS JUDGED TO BE INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORIF OF THE DISTAL RADIUS, THE SURGEON WAS PUTTING ON THE 2.4MM VA LOCKING DORSAL DISTAL RADIUS PLATE. THE SURGEON THEN NEEDED TO REMOVE 1 SCREW TO REPOSTITON IT BUT THE VA LOCKING SCREW WAS STUCK UNDER THE LIP OF THE SCREW HOLE ON THE PLATE. SURGEON HAD TO REMOVE THE PLATE AND 3 SCREWS. HE TESTED THE HOLE IN THE PLATE WITH A NEW SCREW OUTSIDE THE SURGICAL FIELD AND IT WORKED FINE. THE SURGEON REPLACED THE SAME PLATE AND REINSERTED TWO ORIGINAL SCREWS AND ONE NEW SCREW, THEY WERE SEATED AND LOCKED IN PROPERLY. COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183697 2.4MM VA LOCKING SCREW STARDRIVE 22MM HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR