BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGETING ARM T2 PROX. HUM.

    MDR report key: 8867810 · Received August 6, 2019

    Report

    Report Number
    0009610622-2019-00608
    Event Type
    Malfunction
    Date Received
    August 6, 2019
    Date of Event
    July 17, 2019
    Report Date
    October 23, 2019
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    UDI-DI
    04546540379658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCE WAS PROVIDED. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED. SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN SERIAL NUMBER OF DEVICE IN ORDER TO IDENTIFY DHR APPLICABLE TO THIS DEVICE. DEVICE DISPOSITION UNKNOWN.

    Description of Event or Problem · 0

    THE DISTAL LOCKING OF THE SHORT PHN IMPLANTS REPEATEDLY RESULTED IN MISSDRILLING. THE MEDICAL PROCEDURE WAS SUCCESSFULLY COMPLETED BY PERFORMING A FREEHAND LOCKING.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF INVESTIGATION, ADDITIONAL INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE DISTAL LOCKING OF THE SHORT PHN IMPLANTS REPEATEDLY RESULTED IN MISDRILLING. THE MEDICAL PROCEDURE WAS SUCCESSFULLY COMPLETED BY PERFORMING A FREEHAND LOCKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657095 TARGETING ARM T2 PROX. HUM. ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL KP240724 04546540379658

    Patients

    Seq Age Sex Outcome Treatment
    1