BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENT HOHMANN RETRACTOR

    MDR report key: 7756672 · Received August 7, 2018

    Report

    Report Number
    3005985723-2018-00463
    Event Type
    Malfunction
    Date Received
    August 7, 2018
    Date of Event
    July 9, 2018
    Report Date
    October 9, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486031909
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO UPDATE SECTIONS BASED ON THE RESULTS OF INVESTIGATION. PER THE MPS, ALL THE RETRACTORS WERE DAMAGED. PRODUCT NOT RETURNED. REFER TO (B)(4). A REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 199 DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON (B)(6) 2018. NO NON-CONFORMANCES WERE IDENTIFIED DURING INSPECTION. A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 210191, LOT NUMBER 37899 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. SYSTEM READY FOR CLINICAL USE. CORRECTIVE ACTION/PREVENTIVE ACTION: NO ACTION IS REQUIRED AT THIS TIME AS THERE IS NO INDICATION TO SUGGEST A PRODUCT NON-CONFORMITY OR UNANTICIPATED HAZARD."

    Description of Event or Problem · 0

    RETRACTOR BADLY DAMAGED DUE TO SAW HITTING IT. PER THE MPS, ALL THE RETRACTORS WERE DAMAGED AND RIGID. CASE TYPE: (B)(6).

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED BY MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    RETRACTOR BADLY DAMAGED DUE TO SAW HITTING IT. PER THE MPS, ALL THE RETRACTORS WERE DAMAGED AND RIGID. CASE TYPE: TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601019 BENT HOHMANN RETRACTOR STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 37899 00848486031909

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization