BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3936305 · Received July 15, 2014

    Report

    Report Number
    2520274-2014-12581
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    (B)(4): IMPLANT DATE FIELD SHOULD BE BLANK. SUBJECT DEVICE WAS NOT IMPLANTED.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4).IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR AN UNKNOWN SCREW. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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: IT WAS REPORTED THAT THE PRODUCTS WERE USED FOR A DISTAL RADIUS FRACTURE CASE. DURING THE OPERATION THE SURGEON REMOVED THE GUIDING BLOCK TO INSERT THE LOCKING SCREW INTO THE FIRST ROW OF THE RADIAL SIDE OF THE PLATE, BUT THE SCREW DID NOT LOCK AND THE SCREW DRIVER KEPT ROTATING. WHEN THE SURGEON CHECKED THE IMAGE, HE FOUND THAT THE SCREW HAD GONE THROUGH THE PLATE. AFTER REMOVING THE SCREW AND THE SURGEON USED ANOTHER ONE, BUT THE RESULT WAS THE SAME. THE SURGEON PROCEEDED ACCORDING TO THE TECHNICAL GUIDE. THERE WAS NO HARM TO THE PATIENT. THERE WAS A FIFTEEN MINUTES SURGICAL DELAY REPORTED. THIS REPORT IS FOR AN UNKNOWN SCREW. THIS REPORT IS 2 OF 3 FOR COMPLAINT COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412341 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR