BEUDAMED
    FDA Adverse Event Other Summary report: N

    COMPRESSX COMPRESSION SCREW

    MDR report key: 1413379 · Received June 15, 2009

    Report

    Report Number
    3007289093-2009-00001
    Event Type
    Other
    Date Received
    June 15, 2009
    Date of Event
    May 18, 2009
    Report Date
    June 8, 2009
    Manufacturer
    EXTREMITY MEDICAL, LLC
    Product Code
    HWC
    PMA / PMN Number
    K0801934
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING ANALYSIS COMPETED. PRE-DRILLING NOT PERFORMED PER SURGICAL TECHNIQUE. THE IMPLANT TIP SHOWED MINOR SPLAYING, BUT WAS INTACT AND A MICRO 1.6 GUIDE WIRE WAS SUCCESSFULLY PASSED THROUGH THE IMPLANT. A REVIEW OF THE INSPECTION DATA, (B) (4) DATED (B) (6) 2009 FOR LOT #JP1035 WAS PERFORMED. THE INSPECTION DATA DID NOT INDICATE ANY OUT OF SPEC DIMENSIONS. THE INTERNAL HEX WAS VERIFIED TO BE WITHIN TOLERANCE. CONCLUSION: THE STRIPPING OF THE HEX IS CONSISTENT WITH SIMILAR TYPE BONE SCREWS AND IS OFTEN THE RESULT OF OVER TORQUING. THE FAILURE OF A NON-CANNULATED EASY OUT STYLE TOOL CONFIRMS EXCESSIVE TORQUE. THE STRIPPING OF THE INTERNAL HEX PREVENTED THE SCREW DRIVE FROM COUNTER-TORQUING THE PRIMARY SCREW DURING REMOVAL AND RESULTED IN THE COMPRESSION SCREW BECOMING DISENGAGED WITH THE PRIMARY SCREW. THE SURGEON USER FAILED TO FOLLOW "STEP 4: DRILL" OUTLINED IN THE COMPRESSX SURGICAL TECHNIQUE (B) (4). THE INSPECTION DATA ON FILE INDICATES THE IMPLANT WAS MANUFACTURED WITHIN SPECIFICATION. THE VISUAL INSPECTION INDICATED THE ENTIRE IMPLANT WAS REMOVED FROM THE PT. THE FAILURE OF THE IMPLANT RESULTED IN PRO-LONGED SURGICAL TIME AND WAS CAUSED FROM USER ERROR.

    Description of Event or Problem · 1

    HOSPITAL DESCRIPTION: EVENT DESC: SURGEON WAS USING TITANIUM SCREW WHEN SCREW BROKE. SCREW RETRIEVED. NO HARM TO PT OR STAFF. THE BROKEN EQUIPMENT WAS GIVEN TO EXTREMITY MEDICAL REP. DID THIS EVENT INVOLVE AN ELECTROPHYSIOLOGY PROCEDURE OR AN ATTEMPTED ELECTROPHYSIOLOGY PROCEDURE? NO. WHAT WAS THE INTENDED PROCEDURE? SUBTALER FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPRESSX COMPRESSION SCREW SCREW, FIXATION, BONE HWC EXTREMITY MEDICAL, LLC JP1035

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR