BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLID SCREWDRIVER, SMALL

    MDR report key: 12333838 · Received August 17, 2021

    Report

    Report Number
    3009996260-2021-00011
    Event Type
    Malfunction
    Date Received
    August 17, 2021
    Date of Event
    July 29, 2021
    Report Date
    August 17, 2021
    Manufacturer
    CONVENTUS FLOWER ORTHOPEDICS
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCREWDRIVER (FIS 100) IS PART OF THE K-WIRE KIT, HAND, SMALL (KWK 100) KIT (GTIN: (B)(4). THIS SELLABLE PART HAS A PRODUCT CODE OF HTY AND IS CLEARED UNDER 510(K) NUMBER K123562. THE STERILE LOT OF THIS SELLABLE PART THAT INCLUDED THE AFFECTED SCREWDRIVER IS 2011321101. THIS LOT INCLUDES HIPP MEDICAL (B)(4)-MANUFACTURED LOTS 0000323379 AND 0000326622. THE EXACT LOT OF THE SCREWDRIVER INVOLVED COULD NOT BE DETERMINED BECAUSE THE PART WAS NOT RECEIVED FOR INSPECTION FOLLOWING THE INCIDENT.

    Description of Event or Problem · 1

    THE EVENT INCLUDED A FRACTURED FLOWER SCREWDRIVER TIP. X-RAY WAS USED TO CONFIRM THAT THE FRACTURED TIP WAS NOT INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1230271 SOLID SCREWDRIVER, SMALL SCREWDRIVER HXX CONVENTUS FLOWER ORTHOPEDICS 0000323379 OR 0000326622

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention