BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TMINI ARRAY FIXATION GUIDE

    MDR report key: 18673298 · Received February 8, 2024

    Report

    Report Number
    3000719653-2024-00003
    Event Type
    Malfunction
    Date Received
    February 8, 2024
    Date of Event
    December 19, 2023
    Report Date
    February 8, 2024
    Manufacturer
    THINK SURGICAL, INC
    Product Code
    OLO
    PMA / PMN Number
    K230202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORT OF THE DIFFICULTY REMOVING THE ARRAY GUIDE FROM THE ARRAY FIXATION PIN COULD BE DUE TO TOLERANCE INTERFERENCE FIT WHERE THE INNER DIAMETER (ID) OF THE ARRAY GUIDE AND THE OUTER DIAMETER (OD) OF THE FIXATION PIN OR OTHER CONTRIBUTING FACTORS. THE SURGEON WAS ABLE TO SUCCESSFULLY PLACE THE FIXATION PINS AND COMPLETED THE SURGERY. NO PATIENT HAS EXPERIENCED HARM OR LONG TERM CONSEQUENCES. HOWEVER, THERE IS POSSIBILITY FOR THE FIXATION PIN TO BE UNABLE TO BE REMOVED FROM THE ARRAY GUIDE AND THE PATIENT BONE. THEREFORE, THINK SURGICAL DECIDED ON 01/31/2024 TO REPORT TO THE FDA AND VOLUNTARILY REMOVE THE ARRAY GUIDE FROM THE FIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PLACEMENT OF THE ARRAY FIXATION PIN USING THE ARRAY GUIDE THE PIN BOUND WITH THE ARRAY GUIDE AND THE USER HAD DIFFICULTY REMOVING THE ARRAY GUIDE FROM THE ARRAY FIXATION PIN. THE SURGEON WAS ABLE TO USE THE TRACKING ARRAY BRACKET FOR PLACEMENT OF THE FIXATION PINS AND SUCCESSFULLY COMPLETED THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68291 TMINI ARRAY FIXATION GUIDE PIN GUIDE OLO THINK SURGICAL, INC 109101 23030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown