BEUDAMED
    FDA Adverse Event Injury Summary report: N

    U-BLADE SET, TI GAMMA3® Ø10.5X105MM

    MDR report key: 4091187 · Received September 16, 2014

    Report

    Report Number
    0009610622-2014-00470
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 12, 2014
    Report Date
    August 19, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K043431
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REFERRING TO PRODUCT INQUIRY THE U-BLADE SET, TI GAMMA3 Ø10.5X105MM IS STATED TO BE THE PRIMARY PRODUCT. NO OTHER ASSOCIATED PRODUCTS WERE REPORTED. REVIEW OF THE DEVICE HISTORY RECORDS OF THE AFFECTED PRODUCT REVEALED NO CONSPICUITY IN MATERIAL OR MANUFACTURING. THE DEVICE REPORTED WAS NOT RETURNED TO STRYKER (B)(4), AS IT IS STILL IMPLANTED. THUS, A PHYSICAL EXAMINATION OF THE BROKEN SCREW WAS NOT POSSIBLE. THE AVAILABLE INFORMATION AND THE X-RAYS PROVIDED WERE FORWARDED TO A CONSULTING HCP FOR REVIEW. HIS COMMENTS: ¿INITIALLY, THE POSITION OF THE U-BLADE LAG SCREW IN THE FEMORAL HEAD WAS CORRECT. THEN, MOST LIKELY CAUSED BY MASSIVE OSTEOPOROSIS, THE U-BLADE LAG SCREW BROKE THROUGH THE FEMORAL HEAD, WHICH HAD RESULTED IN THE SIGNIFICANT DEFORMATION OF THE U-BLADE. BASED ON THE LIMITED INFORMATION GIVEN A MORE PRECISE STATEMENT IS NOT POSSIBLE FROM A CLINICAL POINT OF VIEW.¿ BASED ON THE ABOVE IT CAN BE ASSUMED THAT THE DISLOCATION OF THE U-BLADE LAG SCREW IS NOT LINKED TO A DEFICIENCY OF THE DEVICE, BUT IS RATHER PATIENT RELATED (MOST LIKELY MASSIVE OSTEOPOROSIS AT THE AGE OF (B)(6) YEARS). FROM A TECHNICAL POINT OF VIEW IT CANNOT BE EXCLUDED THAT THE DISLOCATION OF THE U-BLADE LAG SCREW WAS CAUSED BY AN INSUFFICIENTLY INSERTED SET SCREW (SEE ¿PACKAGING INSERT/IFU, PROCEDURE, AND/OR LITERATURE REVIEW¿). NEVERTHELESS, THE EXACT ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED WITH THE LIMITED INFORMATION GIVEN. REVIEW OF COMPLAINT HISTORY, CAPA DATABASES AND RISK ANALYSIS DID NOT IDENTIFY ANY CONSPICUITY. 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 NON-CONFORMITY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, GAMMA3 ULAG SCREW SURGERY WAS PERFORMED. TWO WEEKS AFTER SURGERY, THE PATIENT COMPLAINED OF PAIN. AT THAT TIME, ULAG SCREW MOVEMENT AND UBLADE DEFORMING WERE FOUND. SCHEDULED FOR REVISION IS UNDECIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, GAMMA3 ULAG SCREW SURGERY WAS PERFORMED. TWO WEEKS AFTER SURGERY, THE PATIENT COMPLAINED OF PAIN. AT THAT TIME, ULAG SCREW MOVEMENT AND UBLADE DEFORMING WERE FOUND. SCHEDULED FOR REVISION IS UNDECIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572855 U-BLADE SET, TI GAMMA3® Ø10.5X105MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K415080

    Patients

    Seq Age Sex Outcome Treatment
    1 101 YR Required Intervention