BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS PST/TFS TOTAL HIP SYS

    MDR report key: 3877725 · Received May 30, 2014

    Report

    Report Number
    3005985723-2014-00068
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 5, 2014
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OQG
    PMA / PMN Number
    K112802
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT WAS INITIATED AT MAKO SURGICAL. THE OPERATING ROOM MGR AT THE SITE CONFIRMED THAT THE SCRUB WAS OUT OF WORK DUE TO A WORK-RELATED INJURY. THERE WAS NO DAMAGE OR DEFECT WITH THE BROACH HANDLE OBSERVED BY THE MAKO REP PRESENT AT THE CASE. THE INSTRUMENT HAS NOT BEEN RETURNED TO MAKO. THE EXTEND OF THE INJURY TO THE SCRUB IS UNK AT THIS TIME SINCE THE INFO PROVIDED IS BASED ON THIRD PARTY FEEDBACK AND NOT OBTAINED DIRECTLY FROM THE SCRUB TECH INVOLVED IN THE EVENT.

    Description of Event or Problem · 1

    THE SURGEON HAD PERFORMED A MAKOPLASTY TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND THE RESTORIS PST/TFS TOTAL HIP SYSTEM ON (B)(6) 2014. AFTER THE SURGEON FINISHED BROACHING, ONE OF THE SCRUB TECHNICIANS ("SCRUB") ACCIDENTALLY PLACED THE BROACH HANDLE IN THE CLEANING POSITION. THE SCRUB WAS ADVISED TO SET THE INSTRUMENT ASIDE FOR THE MAKO REP TO HANDLE. THE SCRUB TRIED TO HELP, AND WHILE TRYING TO DISENGAGE THE LOCKING MECHANISM, SHE ALLEGEDLY CAUGHT ONE OF HER FINGERS BETWEEN THE LOCKING MECHANISM AND THE ACTUAL HANDLE OF THE BROACH. THE SCRUB STATED THAT NO INJURY HAD OCCURRED, AND CONTINUED WITH THE CASE. A FEW DAYS LATER, MAKO WAS INFORMED BY OTHER HOSPITAL STAFF THAT THE SCRUB EXPERIENCED A HAND INJURY, AND WAS SEEING A HAND SPECIALIST. THE STAFF ALSO STATED THAT THE INSTRUMENT MAY HAVE BROKEN THE GLOVE, AND THAT THE SCRUB WAS SEEKING TREATMENT FOR THAT HAZARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319391 RESTORIS PST/TFS TOTAL HIP SYS ARTIFICAL TOTAL HIP REPLACEMENT OQG MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYS (RIO)