BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REF BALL JNT SCREWDRIVER SHAFT

    MDR report key: 12051892 · Received June 23, 2021

    Report

    Report Number
    1020279-2021-05375
    Event Type
    Injury
    Date Received
    June 23, 2021
    Date of Event
    June 9, 2021
    Report Date
    August 4, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HXX
    UDI-DI
    03596010454201
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING AN UNSPECIFIED SURGERY, THE TIP OF A REF BALL JNT SCREWDRIVER SHAFT (CASE (B)(4)) BROKE OFF. NO SIGNIFICANT SURGICAL DELAY OCCURRED, AS A SMITH AND NEPHEW BACKUP DEVICE WAS AVAILABLE TO CONCLUDE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED TO OCCUR DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948342 REF BALL JNT SCREWDRIVER SHAFT SCREWDRIVER HXX SMITH & NEPHEW, INC. 71362295 UNK 03596010454201

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention