BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLECRANON OSTEOTOMY NAIL

    MDR report key: 3870207 · Received June 12, 2014

    Report

    Report Number
    2520274-2014-11793
    Event Type
    Injury
    Date Received
    June 12, 2014
    Report Date
    May 15, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    PK073402
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    A REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED: SYNTHES (B)(4) MANUFACTURED THE OLECRANON OSTEOTOMY NAIL, PART NUMBER 02.007.001, AND LOT NUMBER 5903749. THERE WERE NO MATERIAL REVIEW REPORTS, NON-CONFORMANCE REPORTS, OR COMPLAINT RELATED ISSUES WITH THIS LOT. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE IMPLANT RECORD HISTORY SUBMITTED BY THE USER FACILITY WITH PART NUMBER INFORMATION CONTAINS AN IMPLANT NOTATION IN THE RECORD OF JANUARY 24, 2013, THE RECORD ALSO INDICATES THE YEAR AS 2014 IN THE HEADER INFORMATION. THE INITIAL REPORT ALSO INDICATES THE YEAR AS 2014 THIS DATE HAS BEEN VERIFIED BY THE SALES CONSULTANT AS CORRECT. THE DATE OF (B)(6) 2014 HAS BEEN ENTERED INTO THIS RECORD AS THE IMPLANT DATE THIS INFORMATION IS ONLY MEANT AS CLARIFICATION OF THE CONFLICTING DATES WITHIN THE QUALITY RECORD. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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

    REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. CORRECTED MANUFACTURER - SHOULD BE SYNTHES (B)(4). CORRECTED DEVICE MANUFACTURE DATE 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

    IT WAS REPORTED THE PATIENT SUFFERED A RIGHT DISTAL HUMERUS FRACTURE ON AN UNKNOWN DATE AND UNDERWENT OPEN REDUCTION INTERNAL FIXATION (ORIF) AND OLECRANON OSTEOTOMY. ON (B)(6) 2014 THE PATIENT RETURNED POST OPERATIVELY WITH NONUNION AND BROKEN HARDWARE. THE OLECRANON OSTEOTOMY NAIL BROKE AND THE NAIL END CAP JUNCTION. ONE OF THE 3.5MM CORTEX SCREWS AND A 2.7MM VARIABLE ANGLE LOCKING SCREW BROKE THAT WERE THROUGH THE MEDIAL DISTAL HUMERUS PLATE. ALL BROKEN HARDWARE WAS REMOVED EXCEPT ONE OF THE BROKEN 3.5MM CORTEX SCREWS. THE DISTAL HUMERUS WAS REVISED ON (B)(6) 2014 WITH 4.5MM RECON PLATE AND OLECRANON OSTEOTOMY WAS PLATED WITH 2.7MM/3.5MM VARIABLE ANGLE OLECRANON 4 HOLE PLATE. THE PATIENT IS STABLE AND THERE WERE NO COMPLICATIONS DURING SURGERY. THIS IS REPORT 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347612 OLECRANON OSTEOTOMY NAIL ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES MONUMENT 5903749

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention