BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE SIMPLE LOCKING INTRA-MEDULLARY (SLIM) SYSTEM

    MDR report key: 11726660 · Received April 26, 2021

    Report

    Report Number
    3000327445-2021-00004
    Event Type
    Injury
    Date Received
    April 26, 2021
    Date of Event
    March 28, 2021
    Report Date
    April 26, 2021
    Manufacturer
    PEGA MEDICAL INC.
    Product Code
    HXX
    UDI-DI
    07540194008367
    PMA / PMN Number
    K192710
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    DURING A REMOVAL PROCEDURE OF A SLIM NAIL, THE THREADS OF THE DRIVER APPEARED DAMAGE AND THE SURGEON WAS UNABLE TO THREAD THE INSTRUMENT INTO THE NAIL. THE SURGEON HAD TO CREATE ANOTHER INCISION AND CUT THE NAIL OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622175 THE SIMPLE LOCKING INTRA-MEDULLARY (SLIM) SYSTEM SLIM DRIVER FOR Ø2.0, 2.6 & 3.2 MM RODS HXX PEGA MEDICAL INC. SLM-DRV123 160421-01 07540194008367

    Patients

    Seq Age Sex Outcome Treatment
    1 Other