BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8MM TI MULTILOC PROX HUMERAL NAIL/RIGHT/CANN/160MM-STER

    MDR report key: 3914857 · Received July 4, 2014

    Report

    Report Number
    3009417901-2014-10018
    Event Type
    Malfunction
    Date Received
    July 4, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    SYNTHES SALZBURG
    Product Code
    HSB
    PMA / PMN Number
    PK103002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. 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. 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 THE PRODUCT IN QUESTION WAS USED FOR A PROXIMAL HUMERAL FRACTURE CASE. AFTER FIXING THE PROXIMAL SCREW HOLE, THE SURGEON DRILLED INTO THE MOST DISTAL SCREW HOLE WITHOUT ANY INTERFERENCE. HOWEVER, AT THE DYNAMIC LOCKING PROXIMAL SCREW HOLE THE DRILL INTERFERED WITH THE NAIL IN QUESTION. THOUGH THE SURGEON ATTEMPTED INSERTION OF THE SCREW BY NOT USING AN AIMING ARM, BUT HE STILL HAD DIFFICULTY IN INSERTING IT, AND THE OPERATION WAS COMPLETED BY FIXING ONLY THE DISTAL SCREW HOLE. THERE WAS A TEN MINUTE DELAY IN THE PROCEDURE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392830 8MM TI MULTILOC PROX HUMERAL NAIL/RIGHT/CANN/160MM-STER ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES SALZBURG 5926539

    Patients

    Seq Age Sex Outcome Treatment
    1