BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM F/IM NAIL-STER

    MDR report key: 3870130 · Received June 12, 2014

    Report

    Report Number
    3000270450-2014-10036
    Event Type
    Injury
    Date Received
    June 12, 2014
    Report Date
    April 22, 2014
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HWC
    PMA / PMN Number
    PK000089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DATE OF BIRTH REPORTED ONLY AS 1924. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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

    ADDITIONAL NARRATIVE: NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A REVISION SURGERY WAS DONE DUE TO FEMORAL DEROTATION. REOPERATION WAS PERFORMED AND CONDITION OF PATIENT IS UNKNOWN, RECOVERY IN PROGRESS. PATIENT WAS REVISED TO ANOTHER NAIL CONSTRUCT. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347971 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM F/IM NAIL-STER SCREW,FIXATION,BONE HWC SYNTHES SELZACH 8580938

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention