BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERISMA-LP

    MDR report key: 7832296 · Received August 30, 2018

    Report

    Report Number
    3009962553-2018-00001
    Event Type
    Malfunction
    Date Received
    August 30, 2018
    Date of Event
    June 6, 2018
    Report Date
    June 19, 2018
    Manufacturer
    CLARIANCE SAS
    Product Code
    NKB
    UDI-DI
    03700780625154
    PMA / PMN Number
    K153326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION AT THE MACROSCOPIC LEVEL REVEALED THAT THE FRACTURE WAS LOCATED AT THE DISTAL TIP OF THE SCREWDRIVER SHAFT. THE FRACTURED TIP WAS NOT PROVIDED FOR ANALYSIS. THE FRACTURE ANALYSIS REPORT SUGGESTS THAT THE DRIVER UNDERWENT A BENDING OVERLOAD ON THE HEX LOBES OF THE SHAFT, ARISING FROM AN IMPROPER HANDLING OF THE INSTRUMENT. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN CONDUCTED. NO ISSUE HAS BEEN IDENTIFIED DURING THE MANUFACTURING AND THE RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. ADDITIONALLY, NO SYSTEMATIC TREND OF SUCH OCCURRENCE HAS BEEN OBSERVED. THEREFORE, NO IMMEDIATE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE DISTAL TIP OF SCREWDRIVER BROKE OFF WHILE INSERTING A POLYAXIAL PEDICLE SCREW. THE BROKEN TIP HAS NOT BEEN RETRIEVED. IT IS CAPTURED IN THE SCREW HEAD INSIDE OF THE PATIENT WITHOUT ANY POSSIBILITY OF MIGRATION. SURGERY WAS COMPLETED WITH NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673660 ERISMA-LP SCREWDRIVER SHAFT NKB CLARIANCE SAS 18911039 H224X 03700780625154

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR