BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECSCR F/CFN/AFN F/SYNREAM

    MDR report key: 2246308 · Received August 8, 2011

    Report

    Report Number
    8030965-2011-00526
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 7, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(6) INDICATES A CLINIC IN (B)(6) REPORTED. DURING INSERTION OF THE CONNECTING SCREW, THE SCREW BROKE AND ALSO JAMMED WITH THE HEAD OF THE NAIL. THE SURGEON TRIED TO REMOVE THE SCREW AND COULD NOT. THE CONNECTING SCREW REMAINS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONNECSCR F/CFN/AFN F/SYNREAM CONNECTING SCREW HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NAIL