BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET ADAPTER T2 SCN

    MDR report key: 6746304 · Received July 27, 2017

    Report

    Report Number
    0009610622-2017-00236
    Event Type
    Malfunction
    Date Received
    July 27, 2017
    Date of Event
    June 30, 2017
    Report Date
    September 29, 2017
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REFERRING TO THE PRODUCT INQUIRY THE TARGET ADAPTER T2 SCN IS THE ONLY REPORTED DEVICE AND THUS CONSIDERED THE PRIMARY PRODUCT. A REVIEW OF THE INSPECTION RECORDS FOR THE REPORTED INSTRUMENT REVEALED NO DISCREPANCIES; NO MANUFACTURING RELATED ISSUES WERE FOUND. FURTHERMORE, AS THE TARGET ADAPTER HAD BEEN IN USE FOR APPROX. 4 YEARS WE PRESUPPOSE THAT IT HAD FULFILLED ITS TASKS IN FORMER SURGERIES AS INTENDED WITHOUT PROBLEMS REPORTED. THIS WAS CONFIRMED BY THE SALES REP WHO STATED: ¿DEVICE WORKED WITHOUT COMPLAINTS CASES PRIOR NOT SURE WHEN DAMAGED.¿ A PHYSICAL EXAMINATION WAS NOT POSSIBLE SINCE THE REPORTED PRODUCT WAS NOT RETURNED TO STRYKER KIEL. BASED ON THE LIMITED INFORMATION GIVEN AND IN ABSENCE OF THE AFFECTED PRODUCT THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. REVIEW OF COMPLAINT HISTORY, CAPA DATABASE, RISK ANALYSIS AND THE LABELING DID NOT IDENTIFY ANY DEVIATIONS. THE REVIEW OF THE RISK ASSESSMENT FOR THE FAILURE MODE INDICATED THE ISSUE WAS ADDRESSED ADEQUATELY. THERE ARE NO ACTIONS IN PLACE RELATED TO THE REPORTED EVENT FOR THE SUBJECT PRODUCT. NO NONCONFORMITY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE IS NOT AVAILABLE TO STRYKER.

    Description of Event or Problem · 1

    SURGEON COMPLAINED THAT TARGETING GUIDE FOR SCN NAIL WAS NOT LOCKING CORRECTLY DURING THE CASE. SURGEON HAD TO "FREEHAND" DISTAL LOCKING SCREWS FOR NAIL.

    Description of Event or Problem · 1

    SURGEON COMPLAINED THAT TARGETING GUIDE FOR SCN NAIL WAS NOT LOCKING CORRECTLY DURING THE CASE. SURGEON HAD TO "FREEHAND" DISTAL LOCKING SCREWS FOR NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529358 TARGET ADAPTER T2 SCN ORTHOPEDIC MANUAL SURGICAL INSTRUMENT. LXH STRYKER TRAUMA KIEL KME904145

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR