BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BODY/STEM SEPARATOR

    MDR report key: 5996877 · Received October 4, 2016

    Report

    Report Number
    0002249697-2016-03143
    Event Type
    Malfunction
    Date Received
    October 4, 2016
    Date of Event
    September 7, 2016
    Report Date
    December 22, 2016
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: PRODUCT NOT RETURNED. AN EVENT REGARDING A FRACTURE OF THE RESTORATION MODULAR BODY/STEM SEPARATOR WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS THE DEVICE WAS NOT RETURNED. -MEDICAL RECORDS RECEIVED AND EVALUATION:NOT PERFORMED AS NO PATIENT DEMOGRAPHICS OR MEDICAL RECORDS WERE PROVIDED. ALSO, THERE IS NO INDICATION THAT THE PATIENT FACTORS CONTRIBUTED TO THE EVENT. -DEVICE HISTORY REVIEW: DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN 4 OTHER EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: NEITHER THE EVENT WAS CONFIRMED NOR THE ROOT COULD BE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND INSUFFICIENT INFORMATION WAS PROVIDED. IF THE DEVICES AND/OR ADDITIONAL INFORMATION ARE RECEIVED, THIS INVESTIGATION WILL BE REOPENED AND RE-EVALUATED.

    Description of Event or Problem · 1

    THE COLLET OF THE RESTORATION MODULAR CONE BODY REMOVER SNAPPED IN THE PROCESS OF TRYING TO DISENGAGE THE PROXIMAL CONE BODY. PROTOCOL WAS FOLLOWED VERY CLOSELY, BUT WHEN THE SURGEON ATTEMPTED TO DISENGAGE THE BODY BY HOLDING THE MODULAR HANDLE AND TWISTING THE JACKSCREW CLOCKWISE THE INSTRUMENT EVENTUALLY GAVE OUT DUE TO THE FORCE APPLIED. THE COLLET'S REVERSE THREADS REMAINED IN THE PULLER, AND THE INSTRUMENT SPLIT INTO TWO PIECES JUST BELOW THE THREADS. THE SURGEON WAS ABLE TO CUT THE COLLET OUT OF THE PROXIMAL BODY WITH A BUZZ SAW.

    Description of Event or Problem · 1

    THE COLLET OF THE RESTORATION MODULAR CONE BODY REMOVER SNAPPED IN THE PROCESS OF TRYING TO DISENGAGE THE PROXIMAL CONE BODY. PROTOCOL WAS FOLLOWED VERY CLOSELY, BUT WHEN THE SURGEON ATTEMPTED TO DISENGAGE THE BODY BY HOLDING THE MODULAR HANDLE AND TWISTING THE JACKSCREW CLOCKWISE THE INSTRUMENT EVENTUALLY GAVE OUT DUE TO THE FORCE APPLIED. THE COLLET'S REVERSE THREADS REMAINED IN THE PULLER, AND THE INSTRUMENT SPLIT INTO TWO PIECES JUST BELOW THE THREADS. THE SURGEON WAS ABLE TO CUT THE COLLET OUT OF THE PROXIMAL BODY WITH A BUZZ SAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649598 BODY/STEM SEPARATOR ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH TDEPE00

    Patients

    Seq Age Sex Outcome Treatment
    1 Other