BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL NAIL, LEFT T2 GTN Ø8X300 MM

    MDR report key: 21510074 · Received March 3, 2025

    Report

    Report Number
    0008031020-2025-00369
    Event Type
    Malfunction
    Date Received
    March 3, 2025
    Date of Event
    February 4, 2025
    Report Date
    May 27, 2025
    Manufacturer
    STRYKER GMBH
    Product Code
    HSB
    UDI-DI
    04546540646293
    PMA / PMN Number
    K101438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONCE THE INVESTIGATION IS COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD BE CONFIRMED, SINCE PHYSICAL EVALUATION REVEALED A WRONG SHAPE NAIL. IT COULD BE VERIFIED THAT IN COMPARISON WITH THE CORRESPONDING DRAWING 68-2122210_REVAA THE MOST PROX. HOLE ABOVE OBLONG HOLE SEEMS TO BE INCORRECT FOR THE DEVICE IN QUESTION FEMORAL NAIL, LEFT T2 GTN Ø8X300 MM, CATALOG # 18500830S / LOT CODE K09F126. THE POSITION OF THE MILLING CORRESPONDS TO THAT OF A FEMORAL NAIL, RIGHT T2 GTN Ø8X300 MM ACCORDING TO THE DRAWING 68-2122211 INSTEAD OF FEMORAL NAIL, LEFT T2 GTN Ø8X300 AS PER DRAWING 68-2122210. THIS WAS CLASSIFIED AS A MANUFACTURING DEVIATION AND WAS ADDRESSED IN ACCORDANCE WITH OUR PROCEDURES WHICH WILL COVER ALL FURTHER ACTIONS NEEDED. IN CASE SUBSTANTIVE INFORMATION BECOMES AVAILABLE IN FUTURE THAT SUGGESTS OTHERWISE WE RESERVE THE RIGHT TO REOPEN THE CASE.

    Description of Event or Problem · 0

    AFTER OPENING THE IMPLANT, THE NAIL WAS PREPARED. WHEN I FELT SOMETHING WAS WRONG AND CHECKED IT BEFORE INSERTING IT INTO THE BODY, I FOUND THAT THE PACKAGE AND THE NAIL ITSELF HAD THE WORD ¿LEFT¿ ENGRAVED ON THEM, BUT IT WAS ACTUALLY A RIGHT-HANDED IMPLANT. THE OPERATION CONTINUED WITH A DIFFERENT SIZE IMPLANT BEING OPENED AND INSERTED.

    Description of Event or Problem · 0

    AFTER OPENING THE IMPLANT, THE NAIL WAS PREPARED. WHEN I FELT SOMETHING WAS WRONG AND CHECKED IT BEFORE INSERTING IT INTO THE BODY, I FOUND THAT THE PACKAGE AND THE NAIL ITSELF HAD THE WORD ¿LEFT¿ ENGRAVED ON THEM, BUT IT WAS ACTUALLY A RIGHT-HANDED IMPLANT. THE OPERATION CONTINUED WITH A DIFFERENT SIZE IMPLANT BEING OPENED AND INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777814 FEMORAL NAIL, LEFT T2 GTN Ø8X300 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER GMBH K09F126 04546540646293

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Male