BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSI FEMORAL HIP IMPLANT IMPACTOR

    MDR report key: 209327 · Received February 3, 1999

    Report

    Report Number
    2952369-1999-00001
    Event Type
    Malfunction
    Date Received
    February 3, 1999
    Date of Event
    January 13, 1999
    Report Date
    February 1, 1999
    Manufacturer
    HAYES MEDICAL, INC.
    Product Code
    HWA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHILE ATTENDING SURGERY WITH DR ON 1/13/99 THE IMPLANT DRIVER INSTRUMENT (1023-0206) BROKE WHILE INSERTING THE CUSTOM IMPLANT INTO THE PATIENT'S FEMUR. THE BREAKAGE OF THE INSTRUMENT WAS NOT NOTICED AT THE TIME OF THE IMPLANTATION. THE INSTRUMENT WAS FOUND TO BE BROKEN BY THE SCRUB TECHNICIAN WHILE CLEANING UP THE STERILE TABLE. THE TECHNICIAN SHOWED THE INSTRUMENT TO DR WHILE HE WAS CLOSING THE WOUND. AFTER LOOKING AROUND THE TABLE AND FLOOR FOR THE POSSIBLE BROKEN PIECE OF THE INSTRUMENT, IT WAS DECIDED TO TAKE SEVERAL X-RAYS OF THE PATIENT'S FEMUR. NO EVIDENCE OF THE BROKEN PIECE APPEARED TO BE INSIDE THE PATIENT'S LEG. THEN THE SUCTION EQUIPMENT WAS X-RAYED TO SEE IF IT WAS SUCTIONED BEFORE CLOSURE. NO EVIDENCE OF THE BROKEN PIECE APPEARED TO BE IN THE SUCTION EQUIPMENT. DR DECIDED TO OPEN THE PARTIALLY CLOSED WOUND AND TAKE A CLOSER LOOK. THERE WAS NO EVIDENCE OF THE BROKEN PIECE IN THE WOUND. THE WOUND WAS THOROUGHLY WASHED AND THE WOUND WAS CLOSED. NO BROKEN PIECE OF THE INSTRUMENT WAS FOUND. THE INSTRUMENT WAS STERILIZED AND PICKED UP BY MEDICAL PERSONNEL TO INVESTIGATE THE INCIDENT FURTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PSI FEMORAL HIP IMPLANT IMPACTOR HIP IMPLANT IMPACTOR (INSTRUMENT) HWA HAYES MEDICAL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention PSI FEMORAL HIP IMPLANT.