BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLECRANON OSTEOTOMY NAIL AND END CAP-STERILE

    MDR report key: 3137697 · Received May 30, 2013

    Report

    Report Number
    8030965-2013-02384
    Event Type
    Injury
    Date Received
    May 30, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 1, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    PMA / PMN Number
    K073402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. IMPLANT DATE REPORTED AS (B)(6) 2012. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THE DEVICE CONFORMED TO SPECIFICATION. THERE WERE NO COMPLAINT RELATED ISSUES WITH THIS COMPLAINT.

    Description of Event or Problem · 1

    PATIENT UNDERWENT REMOVAL OF AN OLECRANON OSTEOTOMY NAIL, END CAP AND TWO LOCKING SCREWS DUE TO A NON-UNION. A CT SCAN WAS DONE BEFORE THE START OF THE CASE TO CONFIRM THE NON-UNION. THE ORIGINAL SURGERY WAS PERFORMED ON AN UNKNOWN DATE IN (B)(6) 2012 FOR A DISTAL HUMERUS FRACTURE. THE SURGEON EXACTED THE OLECRANON OSTEOTOMY NAIL CONSTRUCT AND REVISED WITH A COMPETITOR¿S DEVICE. THIS IS 1 OF 3 REPORTS FOR THE SAME EVENT, COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239177 OLECRANON OSTEOTOMY NAIL AND END CAP-STERILE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES GMBH 3163314

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention