BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW,FIXATION,BONE

    MDR report key: 4220041 · Received November 3, 2014

    Report

    Report Number
    2520274-2014-14454
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    January 15, 2014
    Report Date
    February 5, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR 1 UNKNOWN CORTEX SCREW. 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON (B)(6) 2014, THE VARIABLE ANGLE LOCKING COMPRESSION PLATE WAS USED FOR A FRACTURE OF DISTAL RADIUS. AFTER USING THE GUIDING BLOCK, THE CORTEX SCREW WAS INSERTED INTO THE COMBINATION HOLE, THE SCREW WAS INSERTED FROM DISTAL SIDE TO RADIUS SIDE. DURING THE SCREW INSERTION OF MOST OF THE DISTAL RADIUS SIDE, THE SCREW WOULD NOT LOCK AT ALL. THE DOCTOR THEN CHECKED BY IMAGE, AND THEN FOUND OUT THAT THE SCREW PENETRATED. THE DOCTOR REMOVED THE SCREW FROM THE DORSAL PART. IT WAS REPORTED THAT DURING THE SCREW INSERTION, THE SURGEON DID NOT HEAR THE CLICK SOUND FROM THE TORQUE LIMITING ATTACHMENT. WHEN THE SURGEON TRIED TO TURN THE DEVICE MOREOVER, IT WENT THROUGH THE PLATE WITH THE METALLIC FRAGMENT IN QUESTION. THE SURGEON CLOSED A SURGICAL INCISION WITHOUT THE SCREW INSERTION INTO THE AFFECTED PLATE HOLE. IT WAS FURTHER REPORTED THERE WAS A 15 MINUTE DELAY AND NO PATIENT HARM. THIS REPORT IS FOR AN UNKNOWN CORTEX SCREW. THIS REPORT IS FOR 1 OF 1 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701710 SCREW,FIXATION,BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention