BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 8 CORDLESS DRIVER

    MDR report key: 21808670 · Received April 9, 2025

    Report

    Report Number
    0001811755-2025-00001
    Event Type
    Malfunction
    Date Received
    April 9, 2025
    Date of Event
    March 23, 2025
    Report Date
    June 3, 2025
    Manufacturer
    STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
    Product Code
    HWE
    UDI-DI
    07613327304459
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON FURTHER REVIEW, THE HANDPIECE DID NOT CAUSE OR CONTRIBUTE TO THE FRACTURE OF THE DRILL BIT. THE HANDPIECE WILL BE DEEMED CONCOMITANT TO THE REPORTED DRILL BIT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DRILL TIP HIT A NAIL, CAUSING THE TIP OF THE DRILL TO SHEAR OFF AND BECOME EMBEDDED IN THE BONE. ADDITIONAL ATTEMPTS ARE BEING MADE TO THE CUSTOMER FOR ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DRILL TIP HIT A NAIL, CAUSING THE TIP OF THE DRILL TO SHEAR OFF AND BECOME EMBEDDED IN THE BONE. UPON FURTHER REVIEW OF THE INFORMATION PROVIDED, THE HANDPIECE DID NOT CAUSE OR CONTRIBUTE TO THE FRACTURE OF THE DRILL BIT. THE HANDPIECE WILL BE DEEMED CONCOMITANT TO THE REPORTED DRILL BIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472180 SYSTEM 8 CORDLESS DRIVER INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 07613327304459

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown