BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAY OF SURGICAL SCREW DRIVERS

    MDR report key: 10829005 · Received November 10, 2020

    Report

    Report Number
    MW5097781
    Event Type
    Malfunction
    Date Received
    November 10, 2020
    Date of Event
    November 3, 2020
    Report Date
    November 6, 2020
    Manufacturer
    SHUKLA MEDICAL, INC.
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FOUR (4) SCREWDRIVER TIPS IN OPERATING ROOM BROKE DURING SURGERY. NO HARM TO PATIENT, NO RETAINED FOREIGN BODY. PENTALOBE S15 SDR777, LOT#0073321; BIOMET POLARIS 5.5 SDR869, LOT# 012973; PENTALOBE S15 SDR777, LOT# 0073321; BIOMET POLARIS 5.5 SDR869, LOT# 0073114. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1279645 TRAY OF SURGICAL SCREW DRIVERS SCREWDRIVER HXX SHUKLA MEDICAL, INC. PENTALOBE S15 0073321
    1279646 TRAY OF SURGICAL SCREW DRIVERS SCREWDRIVER HXX SHUKLA MEDICAL, INC. PENTALOBE S15 0073321
    1279647 TRAY OF SURGICAL SCREW DRIVERS SCREWDRIVER HXX SHUKLA MEDICAL, INC. POLARIS 5.5 012973
    1279648 TRAY OF SURGICAL SCREW DRIVERS SCREWDRIVER HXX SHUKLA MEDICAL, INC. POLARIS 5.5 0073114

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR