BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOLUCENT WRIST FIXATOR KIT, STERILE

    MDR report key: 2181592 · Received July 5, 2011

    Report

    Report Number
    9680825-2011-00008
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    May 20, 2011
    Report Date
    June 30, 2011
    Manufacturer
    ORTHOFIX SRL
    Product Code
    JDW
    PMA / PMN Number
    K955848
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED FIXATOR, RECEIVED ON (B)(4) 2011, IS CURRENTLY UNDER INVESTIGATION. A CLINICAL EVALUATION OF THE X-RAYS OF THE CASE WAS NOT POSSIBLE AS THE X-RAYS HAVE NOT BEEN MADE AVAILABLE, UNTIL NOW. WE HAVE CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THIS SPECIFIC LOT BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. ACCORDING TO OUR HISTORICAL RECORDS, NO OTHER SIMILAR FAILURES HAVE BEEN REPORTED FROM THIS SPECIFIC PRODUCT LOT. ADDITIONAL DATA WILL BE PROVIDED ONCE THE TECHNICAL INVESTIGATION REPORT AND/OR FURTHER INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    A (B)(6) PATIENT HAD A RADIOLUCENT WRIST FIXATOR PLACED ON (B)(6) 2011, AT (B)(6) IN (B)(6) FOR LEFT DISTAL RADIUS FRACTURE. THE PATIENT CAME TO DOCTOR'S OFFICE ON (B)(6) 2011. THE PATIENT STATED THAT ON (B)(6), HE WAS WALKING FROM ONE ROOM TO ANOTHER AND FELT A SNAP IN THE DEVICE. THE SQUARE PIN APPEARED TO HAVE SNAPPED OFF AT THE CONNECTION AND THERE IS A CRACK ON THE OTHER SIDE. THE PATIENT WAS TO WEAR THE WRIST FIXATOR FOR 2 MORE WEEKS BUT HAD TO BE REMOVED. THE PATIENT WAS CASTED TO STABILIZE THE BONES AND THE FRACTURE APPEARED STABLE AND ALIGNED PER X-RAY ON (B)(6) 2011. NO ADVERSE EVENTS HAVE BEEN REPORTED FOR THE PATIENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIOLUCENT WRIST FIXATOR KIT, STERILE RADIOLUCENT WRIST FIXATOR KIT, STERILE JDW ORTHOFIX SRL 99-36501 V1151404

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR