BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAIL, FIXATION, BONE

    MDR report key: 3942129 · Received July 17, 2014

    Report

    Report Number
    2520274-2014-12651
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    JDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR THE NAIL, PART AND LOT NUMBER UNKNOWN. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING AN OPERATION ON THE SHAFT OF FEMUR THE SURGEON USED AN EXPERT ANTEGRADE FEMORAL NAIL (AFN) (B)(6) DISTAL AIMING DEVICE. DURING DRILLING THE MOST DISTAL PART, THE SURGEON FOUND THAT THE DRILL TIP WAS BLUNT, AND THE DRILLING WAS DULL. THEN, WHEN DRILLING THE NEAREST PART OF THE DISTAL DYNAMIC LOCKING, THE DRILL INTERFERED WITH THE NAIL. THE SURGEON REMOVED THE DRILL TIP, HIT IT WITH A HAMMER AND THE DRILL WENT THROUGH THE NAIL HOLE. THE SURGEON CHECKED THE IMAGE AND FOUND THAT THE DRILL TIP HAD BENT, HE ATTACHED A T-HANDLE TO THE DRILL TIP TO REMOVE IT. HE WAS NOT ABLE TO REMOVE THE DRILL TIP BY HAND, SO HE HAD USED A HAMMER, AND FOUND THAT THE DRILL TIP HAD BROKEN AT THE CONNECTION PART, USING A T-HANDLE AGAIN, THE SURGEON WAS FINALLY ABLE TO REMOVE THE DRILL TIP. THE SURGEON ALSO REPORTED IT WAS DIFFICULT TO DETACH THE AIMING DEVICE FROM THE PROTECTION SLEEVE. IT WAS REPORTED THIS RESULTED IN A 20 MINUTE DELAY AND NO RESIDUE WAS LEFT IN THE PATIENT. THIS REPORT IS FOR THE NAIL, PART AND LOT NUMBER UNKNOWN THIS IS REPORT 3 OF 3 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420423 NAIL, FIXATION, BONE JDS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1