BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9.5MM TI MULTILOC PROX HUMERAL NAIL/RT/CANN/160MM-STER

    MDR report key: 3961498 · Received July 28, 2014

    Report

    Report Number
    2520274-2014-12864
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HSB
    PMA / PMN Number
    PK103002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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. 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 WHEN THE SURGEON WAS DRILLING FOR A PROXIMAL HUMERUS FRACTURE, THE 3.2MM DRILL BIT COULD NOT PASS THROUGH THE SCREW HOLE AND INTERFERED WITH THE NAIL. THE SURGEON MADE AN ADDITIONAL INCISION AND SUCCEEDED IN DRILLING WITH THE 3.2MM DRILL BIT AND SCREW INSERTION. THREE MULTI-LOCK SCREWS WERE INSERTED FOR PROXIMAL LOCKING AND THE 4.0MM LOCKING SCREW WAS INSERTED FOR DISTAL LOCKING. DUE TO THE INCIDENT, THE OPERATION WAS EXTENDED FOR 30 MIN. THIS IS REPORT 1 OF 2 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438018 9.5MM TI MULTILOC PROX HUMERAL NAIL/RT/CANN/160MM-STER ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention