BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K2M SLAP HAMMER

    MDR report key: 15371391 · Received September 6, 2022

    Report

    Report Number
    MW5111897
    Event Type
    Malfunction
    Date Received
    September 6, 2022
    Date of Event
    August 31, 2022
    Report Date
    September 2, 2022
    Manufacturer
    STRYKER / K2M, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING SPINAL FUSION SURGERY A K2M SLAP HAMMER WAS BEING USED. THE BALL BEARING AND A SPRING BROKE OFF OF THE SLAP HAMMER. THIS DID NOT CAUSE HARM TO THE PATIENT. IT WAS FOUND ON THE FLOOR OF THE OPERATING ROOM. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1665660 K2M SLAP HAMMER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER / K2M, INC. 3201-90267 HCGI

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male