BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANCELLOUS SCREW AXSOS 3 TI Ø4.0MM / L24MM / FULL THREAD

    MDR report key: 8324475 · Received February 9, 2019

    Report

    Report Number
    0008031020-2019-00059
    Event Type
    Malfunction
    Date Received
    February 9, 2019
    Date of Event
    January 3, 2019
    Report Date
    February 9, 2019
    Manufacturer
    STRYKER GMBH
    Product Code
    HRS
    UDI-DI
    07613252578505
    PMA / PMN Number
    K181091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT THAT CANCELLOUS SCREW AXSOS 3 TI Ø4.0MM / L24MM / FULL THREAD WAS ALLEGED OF 'BREAKAGE DURING SURGERY' COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT SUCH AS THE LOT NUMBERS OF THE REPORTED PRODUCT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. INDEED, WITH THE PROVIDED INFORMATION, IT IS UNCLEAR HOW OR WHERE THE DEVICE BROKE. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED. NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PHARMACIST FROM THE HOSPITAL REPORTED TO THE SALES REP, THE FOLLOWING EVENT : "OSTEOSYNTHESIS RIGHT HUMERUS FRACTURE / PLATE PLACEMENT 3 SPONGY SCREWS BROKE AND THEN A CORTICAL SCREW DURING INSTALLATION. IT WAS SPONGY SCREW DIAMETER 4 REF 607322 /607324/607328 A LOCKING SCREW ALSO BROKE DURING INSTALLATION REF 661034. NO CONSEQUENCE FOR THE PATIENT: SLIGHTLY INCREASED OPERATING TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117590 CANCELLOUS SCREW AXSOS 3 TI Ø4.0MM / L24MM / FULL THREAD PLATE, FIXATION, BONE HRS STRYKER GMBH UNKNOWN 07613252578505

    Patients

    Seq Age Sex Outcome Treatment
    1 Other