BEUDAMED
    FDA Adverse Event Summary report: N

    ACUFEX TRAIL BLAZER (WITH NNULATED0 ( PROTOTYPE)

    MDR report key: 9720 · Received August 2, 1993

    Report

    Report Number
    9720
    Date Received
    August 2, 1993
    Report Date
    July 23, 1993
    Manufacturer
    ACUFEX MICROSURGICAL, INC.
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    THIS INSTRUMENT WAS USED DURING A TOTAL KNEE REPLACEMENT ON JANUARY 13, 1993 AND REPORTEDLY A FRAGEMNT OF THE INSTRUMENT "FLAKED" OFF AN ARTHROSOCOPY WAS PERFORMED ON JANUARY 20, 1993 TO REMOVE THE METAL CHIP.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUFEX TRAIL BLAZER (WITH NNULATED0 ( PROTOTYPE) ACUFEX MICROSURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Invalid Data