BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAVER BLADE AGGRESSIVE PLUS FORMULA SERIES RED/BLUE

    MDR report key: 8742164 · Received June 27, 2019

    Report

    Report Number
    2134070-2019-00138
    Event Type
    Malfunction
    Date Received
    June 27, 2019
    Date of Event
    May 29, 2019
    Report Date
    June 4, 2019
    Manufacturer
    STERILMED, INC.
    Product Code
    HRX
    UDI-DI
    10888551030069
    PMA / PMN Number
    K012536
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE ARTHROSCOPY PARTIAL MENISCECTOMY PROCEDURE WITH A SHAVER BLADE AGGRESSIVE PLUS FORMULA SERIES RED/BLUE AND THE TIP OF THE SHAVER FELL OFF INTO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON JULY 22, 2019 THAT THE DEVICE WAS DISCARDED. SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, NO VISUAL OR FUNCTIONAL ANALYSIS COULD NOT BE CONDUCTED. THEREFORE, THE REPORTED ISSUE COULD NOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT# 2081940, AND NO NON-CONFORMANCES WERE IDENTIFIED. PER THE FAILURE MODE AND EFFECTS ANALYSIS FOR ORTHOPEDIC SHAVERS AFTER RISK CONTROL MEASURES, THE POTENTIAL CAUSE OF FRAGMENTS OF A DEVICE BREAK/FALL DURING PROCEDURE ARE DEVICE MALFUNCTION, PHYSICIAN MISUSE, MISALIGNMENT/MISMATCH OF SHAFT AND SLEEVE. AFTER RISK CONTROL MEASURES, THE RISK LEVEL IS DETERMINED TO BE LOW/BROADLY ACCEPTABLE. MANUFACTURER'S REF. NO: (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED FOR ANALYSIS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE ARTHROSCOPY PARTIAL MENISCECTOMY PROCEDURE WITH A SHAVER BLADE AGGRESSIVE PLUS FORMULA SERIES RED/BLUE AND THE TIP OF THE SHAVER FELL OFF INTO THE PATIENT. THE TIP WAS SUCCESSFULLY REMOVED THROUGH A TROCAR, WHICH SLOWED DOWN THE PROCEDURE. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532210 SHAVER BLADE AGGRESSIVE PLUS FORMULA SERIES RED/BLUE ARTHROSCOPE HRX STERILMED, INC. 2081940 10888551030069

    Patients

    Seq Age Sex Outcome Treatment
    1