BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U-BLADE SET, TI GAMMA3® Ø10.5X90MM

    MDR report key: 6462179 · Received April 5, 2017

    Report

    Report Number
    0009610622-2017-00105
    Event Type
    Malfunction
    Date Received
    April 5, 2017
    Date of Event
    March 13, 2017
    Report Date
    June 22, 2017
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K043431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    REFERRING TO THE PRODUCT INQUIRY THE U-BLADE SET, TI GAMMA3® Ø10.5X90MM IS THE ONLY REPORTED DEVICE AND THUS CONSIDERED THE PRIMARY PRODUCT. AS THE REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO DISCREPANCIES, WE EXCLUDE DEVIATIONS IN MANUFACTURING. A PHYSICAL EXAMINATION OF THE ITEM WAS NOT POSSIBLE AS IT WAS NOT RETURNED FOR EVALUATION (DISCARDED). THUS, A REASONABLE EXAMINATION WAS NOT POSSIBLE. THE OPERATIVE TECHNIQUE G3-ST-2 (GAMMA 3 RC LAG SCREW OPTECH) WAS REVIEWED FOR THIS CASE AND INFORMS THAT THE GAMMA3 RC U-CLIP INSERTER IS DESIGNED TO PROVIDE THE FORCE THAT WILL BRING THE GAMMA3 RC U-CLIP IN ITS FINAL POSITION, BY SPREADING THE U-CLIP. FOR MORE DETAILS, PLEASE REFER TO THE OPERATING PROCEDURE IN OPTECH. THE INSTRUCTIONS FOR USE L22000007 REV. AA, 01-2016 (NON-ACTIVE IMPLANT) ADVICES TO ENSURE THAT YOU ARE FAMILIAR WITH THE INTENDED USES, INDICATIONS/CONTRAINDICATIONS, COMPATIBILITY AND CORRECT HANDLING OF THE IMPLANT, WHICH ARE DESCRIBED IN THE OPERATIVE TECHNIQUE MANUAL FOR THE PRODUCT SYSTEM. FOR FURTHER DETAILS PLEASE REFER TO THE INSTRUCTIONS FOR USE AS MENTIONED ABOVE. 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. REVIEW OF COMPLAINT HISTORY, CAPA DATABASES AND RISK ANALYSIS DID NOT IDENTIFY ANY COMPLICITY. THE REVIEW OF THE RISK ASSESSMENT FOR THE FAILURE MODE INDICATED THE ISSUE WAS ADDRESSED ADEQUATELY. THERE ARE NO OPEN ACTIONS IN PLACE RELATED TO THE REPORTED EVENT FOR THE SUBJECT PRODUCT. NO NON-CONFORMITY WAS IDENTIFIED. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 1

    ATTEMPTED TO INSERT THE U BLADE, BUT COULDN'T INSERT THE UBLADE ABOUT 80 MM IN FRONT OF U CONNECTOR. SO REMOVED U BLADE AND IT COOULDN'T USE U BLADE IN THIS PROCEDURE. CONTINUING THIS PROCEDURE WITHOUT U BLADE.

    Description of Event or Problem · 1

    ATTEMPTED TO INSERT THE U-BLADE, BUT COULDN'T INSERT THE U BLADE ABOUT 80 MM IN FRONT OF U-CONNECTOR. SO REMOVED U-BLADE AND IT COULDN'T USE U-BLADE IN THIS PROCEDURE. CONTINUING THIS PROCEDURE WITHOUT U-BLADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244400 U-BLADE SET, TI GAMMA3® Ø10.5X90MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K0C3156

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other