BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLECRANON OSTEOTOMY END CAP

    MDR report key: 3192987 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-03752
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    November 23, 2011
    Report Date
    December 9, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    PMA / PMN Number
    K073402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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. (B)(6). THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. NO MANUFACTURING DEFICIENCIES WERE NOTED. THE ADDITIONAL EVALUATION VISUAL INSPECTION HAS SHOWN THAT THE INNER THREAD OF THIS END CAP IS DAMAGED. WE ARE NOT AWARE OF ANY FURTHER COMPLAINTS WITH THIS PHENOMENON. WE ARE NOT ABLE TO GIVE A CONCLUSIVE STATEMENT REGARDING A POSSIBLE FAILURE REASON. THIS ARTICLE WAS MANUFACTURED ACCORDING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END CAP COULD NOT BE CONNECTED WITH THE NAIL. THE IMPLANT COULD NOT BE CONNECTED ON THE BOTTOM PART OF THE NAIL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294555 OLECRANON OSTEOTOMY END CAP HSB SYNTHES GMBH 5907816

    Patients

    Seq Age Sex Outcome Treatment
    1