BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-WIRE GAMMA 3,2X450 MM

    MDR report key: 11189697 · Received January 18, 2021

    Report

    Report Number
    0009610622-2021-00236
    Event Type
    Malfunction
    Date Received
    January 18, 2021
    Date of Event
    June 23, 2020
    Report Date
    April 15, 2021
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    UDI-DI
    04546540175366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD BE CONFIRMED, SINCE THE XRAY WAS PROVIDED THAT MATCHES THE ALLEGED FAILURE MODE. THE DEVICE INSPECTION WAS NOT POSSIBLE AS THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. 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. 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. HOWEVER, IN GENERAL BREAKAGE OF K-WIRE TIP COULD BE DUE TO HANDLING FAILURE OR MECHANICAL OVERSTRESSING. IF DEVICE IS RETURNED OR ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE REASSESSED.

    Description of Event or Problem · 0

    AS REPORTED: "I WAS MADE AWARE TODAY THAT THE TIP OF A GAMMA GUIDE WIRE ITEM # 1210-6450S (LOT# K0E3549) BROKE OFF INSIDE THE GREATER TROCH REGION WHILE THEY WERE ATTEMPTING TO GET THE STARTING POINT FOR AN ALPHA GT NAIL ON (B)(6) 2020. THEY DECLINED TO REMOVE THE TIP OF THE WIRE BECAUSE IT WOULD HAVE CAUSED MORE DAMAGE TO DO SO. THE PROCEDURE CONTINUED AND WAS COMPLETED WITHOUT FURTHER ISSUE OR SURGICAL DELAY."

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE IS NOT AVAILABLE; DISPOSED BY HOSPITAL.

    Description of Event or Problem · 1

    AS REPORTED: "I WAS MADE AWARE TODAY THAT THE TIP OF A GAMMA GUIDE WIRE ITEM # 1210-6450S (LOT# K0E3549) BROKE OFF INSIDE THE GREATER TROCH REGION WHILE THEY WERE ATTEMPTING TO GET THE STARTING POINT FOR AN ALPHA GT NAIL ON (B)(6) 2020. THEY DECLINED TO REMOVE THE TIP OF THE WIRE BECAUSE IT WOULD HAVE CAUSED MORE DAMAGE TO DO SO. THE PROCEDURE CONTINUED AND WAS COMPLETED WITHOUT FURTHER ISSUE OR SURGICAL DELAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81065 K-WIRE GAMMA 3,2X450 MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL 1210-6450S K0E3549 04546540175366

    Patients

    Seq Age Sex Outcome Treatment
    1