BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAMER HANDLE OFFSET

    MDR report key: 24400660 · Received February 20, 2026

    Report

    Report Number
    3005985723-2026-00091
    Event Type
    Malfunction
    Date Received
    February 20, 2026
    Date of Event
    January 21, 2026
    Report Date
    February 20, 2026
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486032142
    PMA / PMN Number
    K170593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS PROVIDED: ON JANUARY 30TH, 2026, LEAD MAKO PRODUCT SPECIALIST REPORTED THAT ON (B)(6) 2026, DURING THE PREPARATION OF INSTRUMENTS PRIOR TO THE START OF SURGERY AT THE FACILITY, THE SCRUB NURSE IT WAS OBSERVED THAT THE OFFSET REAMER HANDLE (REF. 212760, LOT: 5860859) WAS DEFECTIVE. IT COULD NOT BE INSERTED THROUGH THE HIP END EFFECTOR, AND UPON CLOSE INSPECTION, SCREWS WERE FOUND TO BE MISSING. AFTER REVIEWING THE PART, IT WAS CONCLUDED THAT THE LOSS OF FUNCTIONALITY RENDERS IT UNUSABLE CLINICALLY, THE UNIT IS NOT REPAIRABLE, AND IT MUST BE REPLACED. IT IS IMMEDIATELY SEPARATED AND IS NOT USED IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338558 REAMER HANDLE OFFSET ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL CORP. 5860859 00848486032142

    Patients

    Seq Age Sex Outcome Treatment
    1