BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BODY/STEM SEPARATOR

    MDR report key: 5233901 · Received November 18, 2015

    Report

    Report Number
    0002249697-2015-03883
    Event Type
    Malfunction
    Date Received
    November 18, 2015
    Date of Event
    October 30, 2015
    Report Date
    October 30, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING ALLEGED DAMAGE INVOLVING A RESTORATION MODULAR BODY/STEM SEPARATOR WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: THE DEVICES WERE RETURNED IN USED CONDITION. THE COLLET WAS ASSEMBLED TO THE PULLER AND COULD NOT BE DISASSEMBLED. THE CONE BODY COULD NOT BE REMOVED FROM THE COLLET/PULLER CONSTRUCT. AFTER THE DEVICES WERE DISASSEMBLED, THE COLLET COULD BE REPEATEDLY ASSEMBLED TO THE PULLER WITHOUT ISSUE. MEDICAL RECORDS RECEIVED AND EVALUATION: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. CONCLUSIONS: THE COLLET AND PULLER SHOWED NO EVIDENCE OF GALLING OR THREAD DAMAGE. THE COLLET COULD BE REPEATEDLY ASSEMBLED TO THE PULLER WITHOUT ISSUE. THE LIKELY CAUSE FOR THIS EVENT WAS INADVERTENT OVER TIGHTENING CAUSED BY THE COLLET BEING REVERSE THREADED TO THE PULLER.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    SURGEON WANTED TO READJUST THE CONE BODY VERSION AFTER IMPACTING THE IMPLANT, USED THE BODY STEM SEPARATOR TO REMOVE THE CONE BODY FROM THE STEM. WHEN THE SURGEON WENT TO DISENGAGE THE DISTAL COLLET TO RELEASE THE BODY HE WAS UNABLE TO UNTHREAD IT. HE WAS ADVISED THAT IT WAS A REVERSE THREAD HOWEVER NEITHER THE SURGEON, SCRUB NURSE OR HIS ASSISTANT WERE ABLE TO UNTHREAD THE COLLET TO RELEASE THE BODY. A REPLACEMENT CONE BODY WAS IMPLANTED. THERE WAS A 30 MINUTE DELAY.

    Description of Event or Problem · 1

    SURGEON WANTED TO READJUST THE CONE BODY VERSION AFTER IMPACTING THE IMPLANT, USED THE BODY STEM SEPARATOR TO REMOVE THE CONE BODY FROM THE STEM. WHEN THE SURGEON WENT TO DISENGAGE THE DISTAL COLLET TO RELEASE THE BODY HE WAS UNABLE TO UNTHREAD IT. HE WAS ADVISED THAT IT WAS A REVERSE THREAD HOWEVER NEITHER THE SURGEON, SCRUB NURSE OR HIS ASSISTANT WERE ABLE TO UNTHREAD THE COLLET TO RELEASE THE BODY. A REPLACEMENT CONE BODY WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763362 BODY/STEM SEPARATOR ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other