BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U-BLADE SET, TI GAMMA3 Ø10.5X95MM

    MDR report key: 4776218 · Received May 15, 2015

    Report

    Report Number
    0009610622-2015-00244
    Event Type
    Malfunction
    Date Received
    May 15, 2015
    Date of Event
    April 28, 2015
    Report Date
    April 28, 2015
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K043431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    REFERRING TO THE PRODUCT INQUIRY THE U-BLADE SET, TI GAMMA3 Ø10.5X95MM IS STATED TO BE THE PRIMARY PRODUCT. NO OTHER ASSOCIATED PRODUCTS WERE REPORTED. THE DEVICE REPORTED WAS NOT AVAILABLE AS IT IS STILL IMPLANTED; THUS, A PHYSICAL EXAMINATION OF THE U-BLADE SET WAS NOT POSSIBLE. REVIEW OF THE DEVICE HISTORY RECORDS OF THE AFFECTED PRODUCT REVEALED NO CONSPICUITIES IN MATERIAL OR MANUFACTURING. THE ITEM WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. ACCORDING TO INFORMATION RECEIVED X-RAYS WERE NOT AVAILABLE. BASED ON THE LIMITED INFORMATION GIVEN THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING GAMMA3 EXTRACTION SURGERY, THE ROOT OF U-BLADE BROKE. THERE WAS NO PROBLEM IN THE EXTRACTION PROCEDURE. FINALLY, U-LAG SCREW AND GAMMA3 NAIL WERE REMAINED IN THE PATIENT BECAUSE A PART OF U-BLADE DID NOT BE REMOVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING GAMMA3 EXTRACTION SURGERY, THE ROOT OF U-BLADE BROKE. THERE WAS NO PROBLEM IN THE EXTRACTION PROCEDURE. FINALLY, U-LAG SCREW AND GAMMA3 NAIL WERE REMAINED IN THE PATIENT BECAUSE A PART OF U-BLADE DID NOT BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319497 U-BLADE SET, TI GAMMA3 Ø10.5X95MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K282298

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other