BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    19MM SHALLOW MILLED BODY COMPONENT 9002-0-5501

    MDR report key: 3830831 · Received May 23, 2014

    Report

    Report Number
    0002249697-2014-01937
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K022549
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING CRACK/FRACTURE INVOLVING A 19MM SHALLOW MILLED BODY COMPONENT (B)(4) WAS REPORTED. THE EVENT WAS CONFIRMED. A MATERIAL ANALYSIS HAS BEEN PERFORMED. THE REPORT CONCLUDED. THE MILLED LOCKING BOLT FRACTURED AT THE ROOT DIAMETER OF THE THIRD THREAD NEAREST THE HEAD. THE MILLED LOCKING BOLT BROKE IN A DUCTILE MANNER DUE TO AN OVERLOAD IN TORSION. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED. SEM/EDS ANALYSIS SHOWED THE RESTORATION MODULAR BOLT TO BE MADE OF A TI-AL-V ALLOY CONSISTENT WITH THE ASTM F136 ALLOY. A MEDICAL REVIEW WAS NOT PERFORMED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATED THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. THE INVESTIGATION CONCLUDED THAT THE FRACTURE WAS CONSISTENT WITH THE APPLICATION OF AN OVERLOAD IN TORSION. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE DEVICE.

    Description of Event or Problem · 1

    LOCKING BOLT FOR PROXIMAL BODY (MILLED) BROKE AT THE THREADS WHEN DOCTOR WAS TORQUE TIGHTENING TO DISTAL STEM. WHEN HE GOT TO 180LBS OF TORQUE, THE SCREW BROKE IN 2 PIECES.

    Description of Event or Problem · 1

    LOCKING BOLT FOR PROXIMAL BODY (MILLED) BROKE AT THE THREADS WHEN DOCTOR WAS TORQUE TIGHTENING TO DISTAL STEM. WHEN HE GOT TO (B)(6) LBS OF TORQUE THE SCREW BROKE IN 2 PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307655 19MM SHALLOW MILLED BODY COMPONENT 9002-0-5501 IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH T57385AA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other