BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOMED, INC.

    MDR report key: 13688946 · Received March 8, 2022

    Report

    Report Number
    1833053-2022-00001
    Event Type
    Malfunction
    Date Received
    March 8, 2022
    Date of Event
    February 4, 2022
    Report Date
    March 9, 2022
    Manufacturer
    INNOMED, INC.
    Product Code
    HWB
    UDI-DI
    00840277101952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER RECEIPT OF THE REPORT, INNOMED CONTACTED THE INITIAL REPORTER AT THE USER FACILITY AND REQUESTED THAT THE AFFECTED DEVICE BE RETURNED FOR INVESTIGATION AND AN EVALUATION. THE USER FACILITY NEVER RESPONDED. INNOMED'S INTERNAL CAPA AND COMPLAINTS DATABASES WERE SURVEYED FOR THE SAME ISSUE WITH THE PART. NO ENTRIES WERE FOUND IN THE CAPA DATABASE. TWO ENTRIES WERE FOUND IN THE COMPLAINTS DATABASE REGARDING THE PART, BUT THE DESCRIBED ISSUES OF THE AFOREMENTIONED ENTRIES WERE NOT THE SAME AS THE DESCRIBED ISSUE OF THE PART REFERENCED IN THIS REPORT. INNOMED WILL AGAIN REACH OUT TO THE INITIAL REPORTER FOR ADDITIONAL INFORMATION AND PROVIDE A FOLLOW UP.

    Additional Manufacturer Narrative · 0

    INNOMED REACHED OUT TO THE USER FACILITY AND AGAIN REQUESTED THAT THE AFFECTED DEVICE RETURNED. CONTACT AT THE USER FACILITY RESPONDED THAT THE ITEM COULD NOT BE LOCATED. RESULTS OF THE TWO (2) SURVEYS REFERENCED IN THE INITIAL REPORT REGARDING THE PART NUMBER DETERMINED THE ISSUES TO BE THE RESULT OF MISUSE. BECAUSE OF THE AFOREMENTIONED STATEMENT, INNOMED WAS NOT ABLE TO PROCURE THE AFFECTED PART FOR INSPECTION AND EVALUATION. THE DESCRIBED ISSUE FOR THE AFFECTED PART IS THE FIRST OF ITS KIND. INNOMED WILL TREND THIS ISSUE TO DETERMINE IF CORRECTIVE MEASURES ARE REQUIRED.

    Description of Event or Problem · 0

    RONGEUR WITH AN ANGLED HANDLE HAD A SCREW FALL OUT DURING SURGERY. AN X-RAY WAS TAKEN IMMEDIATELY TO VERIFY THAT NO FOREIGN PIECES FROM THE RONGEUR WERE RETAINED. THE INSTRUMENT WAS THEN REMOVED FROM THE STERILE FIELD.

    Description of Event or Problem · 0

    RONGEUR WITH AN ANGLED HANDLE HAD A SCREW FALL OUT DURING SURGERY. AN X-RAY WAS TAKEN IMMEDIATELY TO VERIFY THAT NO FOREIGN PIECES FROM THE RONGEUR WERE RETAINED. THE INSTRUMENT WAS THEN REMOVED FROM THE STERILE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1479297 INNOMED, INC. RONGEUR HWB INNOMED, INC. 1780-02 00840277101952

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male