BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RSP SHOULDER

    MDR report key: 2566638 · Received May 4, 2012

    Report

    Report Number
    1644408-2012-00238
    Event Type
    Malfunction
    Date Received
    May 4, 2012
    Date of Event
    April 24, 2012
    Report Date
    April 24, 2012
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2012 AN AGENT REPORTED A DRILL BIT WAS BROKE WHILE THE SURGEON WAS DRILLING THE GLENOID. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. THERE WAS A 20 MINUTE DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE SHANK OF THE DRILL BIT WAS RETURNED TO DJO SURGICAL FOR EXAMINATION. THE DISTAL CUTTING TIP WAS REPORTED TO HAVE BEEN DISPOSED OF IN THE SHARPS BIN AT THE HOSPITAL AND UNABLE TO BE RETRIEVED. A REVIEW OF THE DEVICE HISTORY RECORD SHOWS THE INSTRUMENT WAS MANUFACTURED BY HURON TOOL AND CUTTER GRINDING CO. FOR DJO SURGICAL. THE DIMENSIONAL INSPECTION RECORDS SHOW THE DEVICE MET THE INTENDED ENGINEERING SPECIFICATIONS. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THIS IS THE (B)(4) COMPLAINT FOR THIS PART NUMBER AND THE SECOND COMPLAINT FOR THIS LOT NUMBER. THERE ARE (B)(4) PRIOR COMPLAINTS INVOLVING A FRACTURE OF THE DRILL BIT. THE ROOT CAUSE OF THIS COMPLAINT IS FRACTURE AT THE ROOT OF THE CUTTING FLUTES FROM FORCES EXCEEDING THE ULTIMATE STRENGTH OF THE MATERIAL. THE CAUSE OF THE FRACTURE CANNOT BE DETERMINED WITH CONFIDENCE, BUT IS MOST COMMONLY ASSOCIATED WITH COMBINED BENDING AND TORSIONAL LOADING SOMETIMES ENCOUNTERED DUE TO THE CONFINED SPACE OF THE SURGICAL SITE.

    Description of Event or Problem · 1

    INSTRUMENT FAILURE - THE SURGEON WAS PERFORMING A SURGERY FOR REVERSE SHOULDER PROSTHESIS, AND WHILE DRILLING THE GLENOID THE DRILL BIT BROKE. THERE WAS A 20 MINUTE DELAY IN ORDER TO REMOVE THE BROKEN BIT FROM THE GLENOID. AFTER REMOVAL OF THE BIT THE SURGERY WAS COMPLETED AS INTENDED; WITH NO OTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER 2.5MM X 127MM DRILL BIT HSD ENCORE MEDICAL, L.P. 38402L01

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention