BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD LAG SCREW OMEGA 90MM LENGTH

    MDR report key: 6926232 · Received October 7, 2017

    Report

    Report Number
    0008031020-2017-00586
    Event Type
    Malfunction
    Date Received
    October 7, 2017
    Date of Event
    September 14, 2017
    Report Date
    January 9, 2018
    Manufacturer
    STRYKER GMBH
    Product Code
    KTT
    PMA / PMN Number
    K955306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROVIDED IMAGES CLEARLY SHOW THAT THE TEETHS OF THE LAG SCREW SHEARED OFF. THE REVIEW OF THE DEVICE DOCUMENTATION REVEALED THE FOLLOWING: A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. THE RISK MANAGEMENT FILE (OMEGA-DQF 45-001 RISK MANAGEMENT FILE-S-RA026) LISTS FOLLOWING CAUSES FOR THE OBSERVED FAILURE: LOCKING INSERT PREVIOUSLY EXTRACTED. TOO HIGH FORCES APPLIED DURING LAG SCREW ASSEMBLY. MULTIPLE DISCONNECTIONS DUE TO INSUFFICIENT ASSEMBLY OF INSTRUMENTS. 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. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE WAS DISPOSED OF.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IMPLANTING THE LAG SCREW THE TEETH SHEARED OFF.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IMPLANTING THE LAG SCREW THE TEETH SHEARED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706740 STANDARD LAG SCREW OMEGA 90MM LENGTH APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT STRYKER GMBH J28634

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other