BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN 2.0 WIRE 3 OF 3

    MDR report key: 7551205 · Received May 29, 2018

    Report

    Report Number
    0008031020-2018-00410
    Event Type
    Malfunction
    Date Received
    May 29, 2018
    Date of Event
    May 2, 2018
    Report Date
    August 9, 2018
    Manufacturer
    STRYKER GMBH
    Product Code
    HSN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT THAT UNKNOWN 2.0MM WIRE WAS ALLEGED OF 'IMPLANT BREAKAGE AFTER SURGERY' COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. HOWEVER, A POTENTIAL ROOT CAUSE COULD BE (BUT NOT LIMITED TO) THAT ONE HEXAPOD STRUT FROM THE FRAME WAS RETURNED BROKEN. THIS BREAKAGE HAS MOST LIKELY WEAKENED THE FRAME AND MIGHT HAVE LEAD TO THE BREAKAGE OF WIRES. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UPON SCHEDULED REMOVAL OF THE EXTERNAL FIXATION CONSTRUCT ON PATIENT'S ANKLE (SIDE NOT REPORTED), A LARGE STRUT WAS OBSERVED TO BE BROKEN APART. THREE 2.0 WIRES WERE ALSO REPORTED BROKEN AT THE JUNCTION OF THE BOLT ADAPTORS. PREVIOUS FOLLOWUP VISITS BY THE PATIENT SHOWED THE ENTIRE CONSTRUCT INTACT.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON SCHEDULED REMOVAL OF THE EXTERNAL FIXATION CONSTRUCT ON PATIENT'S ANKLE (SIDE NOT REPORTED), A LARGE STRUT WAS OBSERVED TO BE BROKEN APART. THREE 2.0 WIRES WERE ALSO REPORTED BROKEN AT THE JUNCTION OF THE BOLT ADAPTORS. PREVIOUS FOLLOWUP VISITS BY THE PATIENT SHOWED THE ENTIRE CONSTRUCT INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393850 UNKNOWN 2.0 WIRE 3 OF 3 IMPLANT HSN STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other