BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-WIRE GAMMA Ø3,2X450 MM

    MDR report key: 14186347 · Received April 22, 2022

    Report

    Report Number
    0009610622-2022-00147
    Event Type
    Malfunction
    Date Received
    April 22, 2022
    Date of Event
    October 11, 2021
    Report Date
    June 13, 2022
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    UDI-DI
    04546540175366
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT 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 AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. 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.

    Description of Event or Problem · 0

    AS REPORTED: "DURING SURGERY ONE OF THE K-WIRES BEING USED REF. (B)(4), LOT: K04043F, EXP, 2626-06-20 BROKE OFF AND LODGED INTO THE LEFT HIP BONE. SURGEON WAS UNABLE TO RETRIEVE THE BROKEN PIECE."

    Description of Event or Problem · 0

    AS REPORTED: "DURING SURGERY ONE OF THE K-WIRES BEING USED REF.(B)(4) , LOT: K04043F, EXP, 2626-06-20 BROKE OFF AND LODGED INTO THE LEFT HIP BONE. SURGEON WAS UNABLE TO RETRIEVE THE BROKEN PIECE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1714593 K-WIRE GAMMA Ø3,2X450 MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL 1210-6450S K04043F 04546540175366

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention