BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER SHAFT T4/66MM

    MDR report key: 2973696 · Received February 22, 2013

    Report

    Report Number
    1719045-2013-00405
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    April 13, 2012
    Report Date
    April 13, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND
    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. MANUFACTURING SITE ADDRESS IS UNKNOWN. ORIGINAL AWARENESS DATE IS (B)(6() 2012. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.(B)(4)

    Description of Event or Problem · 1

    DURING A DISTAL RADIUS FRACTURE CASE WHILE INSERTING THE SCREWS, THE STAR DRIVE SCREWDRIVER TIP BROKE OFF INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED AND SURGEON USED ANOTHER DRIVER TO COMPLETE THE PROCEDURE WITH NO FURTHER INCIDENT. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR FILE (B)(4).

    Description of Event or Problem · 1

    CORRECTION TO THE COMPLAINT DESCRIPTION FROM DISTAL RADIUS FRACTURE TO METACARPAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77689 STARDRIVE SCREWDRIVER SHAFT T4/66MM STARDRIVE SCREWDRIVER SHAFT HXX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR