BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 4221668 · Received November 3, 2014

    Report

    Report Number
    0002249697-2014-04114
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    HTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING CRACK/FRACTURE INVOLVING AN OTHER HIP HANDLE WAS REPORTED. CONCLUSIONS: THE RETURNED DEVICE IS AN OEM PRODUCT. THE SUPPLIER WAS NOTIFIED OF THE EVENT AND FURTHER INVESTIGATION WILL BE PERFORMED. A PREVIOUS INVESTIGATION HAS BEEN COMPLETED FOR THE SAME PRODUCT AND OEM SUPPLIER, AND IT HAS BEEN VERIFIED THAT THE QUALITY AGREEMENT REFERENCED WITHIN IS CURRENT AND VALID.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN OFF SET REAMER HANDLE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PRIMARY LEFT HIP SURGERY, THE OFF SET REAMER HANDLE WAS BROKEN. SURGERY WAS DELAY BY 10 MINUTES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PRIMARY LEFT HIP SURGERY, THE OFF SET REAMER HANDLE WAS BROKEN. SURGERY WAS DELAY BY 10 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703150 UNKNOWN_RECONSTRUCTIVE_PRODUCT INSTRUMENT HTO STRYKER ORTHOPAEDICS-MAHWAH 71246600001-01

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other