BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHROSCOPY BLADE

    MDR report key: 2973908 · Received February 14, 2013

    Report

    Report Number
    MW5029039
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 14, 2013
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    HRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    I SUBMITTED A MEDWATCH REPORT ON (B)(6) RELATED TO APPARENT METALLIC FRAGMENTS FROM AN ARTHROSCOPIC CUTTING BLADE. WE HAVE SUBSEQUENTLY CONFIRMED THROUGH SCANNING ELECTRON MICROSCOPY AND ENERGY-DISPERSIVE X-RAY SPECTROSCOPY (SEM/EDS) THAT THE FRAGMENTS IDENTIFIED IN THE SURGICAL PATHOLOGY SPECIMEN WERE STAINLESS STEEL AND THAT THE SPECTROSCOPY MATCHES THE COMPOSITION OF THE CUTTING BLADE. THE ELECTRON MICROSCOPY ALSO INDICATES FRAGMENTS ON THE TEETH OF AN UNUSED CUTTING BLADE.

    Description of Event or Problem · 1

    PATIENT HAD A PRE-OPERATIVE DIAGNOSIS OF RIGHT SHOULDER LABRAL TEAR. DURING AN ARTHROSCOPIC SHOULDER PROCEDURE RIGHT SHOULDER ARTHROSCOPY WITH LIMITED LABRAL DEBRIDEMENT, LIMITED SYNOVECTOMY SURGICAL LIGHTING AND PICTURES INDICATE SHINY REFLECTIVE PARTICLES NOT TRADITIONALLY OBSERVED DURING THIS PROCEDURE WHICH CAUSED CONCERN TO THE SURGEON TO WARRANT STOPPING THE PROCEDURE AND FURTHER ANALYSIS. THE FOLLOWING DETAILS INFO FROM THE SURGICAL REPORT: WHILE SHAVING THE LABRAL EDGE, SMALL AREAS OF DARK DISLOCATION WERE NOTED REMAINING ON THE TISSUE. WHEN VIEWED CLOSELY, THEY OCCASIONALLY REFLECTED LIGHT FROM THE SCOPE. THE FINDINGS WERE HIGHLY SUSPICIOUS THESE WERE MICROSCOPIC METALLIC FOREIGN BODIES ARISING FROM THE SHAVER BLADES. DEBRIDEMENT WAS DISCONTINUED AND THE SHAVER AND TIP QUARANTINED UNTIL BIOMED COULD COLLECT THEM. AS MUCH OF THE MATERIAL AS POSSIBLE WAS REMOVED WITH PUNCH FORCEPS. A COUPLE OF VERY SMALL FRAGMENTS WERE ADHERENT TO THE SURFACE OF THE GLENOID ARTICULAR CARTILAGE AND WERE NOT REMOVABLE WITH GENTLE ATTEMPTS TO ASPIRATE, OR GRASP THEM. IT WAS FELT THAT THE DEFECTS CREATED FOLLOWING AGGRESSIVE ¿DIGGING¿ TO REMOVE THE FRAGMENTS WOULD HAVE A GREATER LIKELIHOOD OF LONG-TERM IMPAIRMENT, SO THE FRAGMENTS WERE LEFT IN SITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66170 ARTHROSCOPY BLADE DISPOSABLE ARTHROSCOPY BLADE HRX STRYKER ENDOSCOPY 0375-544-000 12306CE2
    66171 STRYKER FORMULA HANDPIECE HANDPIECE HWE STRYKER ENDOSCOPY

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other