BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-03516

    MDR report key: 3183035 · Received June 21, 2013

    Report

    Report Number
    2520274-2013-03516
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    September 30, 2011
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    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. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    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.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SCREWS BROKE DURING INSERTION. THE DOCTOR HAD PROBLEMS WITH INSERTION OF CORTEX 2.7 AND LOCKING 2.7 SCREWS, IN ONE CASE A CORTEX SCREW AND A LOCKING SCREW BROKE OFF DURING INSERTION. THE BROKEN SCREW SHAFT WAS LEFT IN THE BONE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4). THIS REPORT IS ON THE CORTEX SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282527 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1