BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENT HOHMANN RETRACTOR

    MDR report key: 9258405 · Received October 30, 2019

    Report

    Report Number
    3005985723-2019-00771
    Event Type
    Malfunction
    Date Received
    October 30, 2019
    Date of Event
    October 18, 2019
    Report Date
    December 30, 2019
    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

    REPORTED EVENT: BENT AND GOUGED. CASE TYPE: NO ASSOCIATED PROCEDURE PRODUCT EVALUATION AND RESULTS: THE PRODUCT IS CONFIRMED TO BE A BENT HOHMANN RETRACTOR, P/N # 210191, LOT NUMBER 42224 PRODUCT HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE 100 DEVICES WERE MANUFACTURED UNDER LOT NO 42224 AND ACCEPTED INTO FINAL STOCK ON 08/24/2018. NO NON-CONFORMANCES WERE IDENTIFIED DURING INSPECTION. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 210191, LOT NUMBER 42224, SHOWS 00 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE EVENT IS CONFIRMED. PER D03391, PREVENTIVE MAINTENANCE IS WHERE AN ACTION OCCURS THAT IDENTIFIES DEVICE DETERIORATION WHICH MAY COMPROMISE FUNCTION. UNDER PM CONDITIONS NO PATIENT WAS INVOLVED AND NO ACTUAL OR POTENTIAL PATIENT HARM EXISTED FOR THE ALLEGED EVENT. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THERE HAVE BEEN NO NC AND CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT.

    Description of Event or Problem · 0

    BENT AND GOUGED. CASE TYPE: NO ASSOCIATED PROCEDURE.

    Additional Manufacturer Narrative · 1

    AS PART OF THE 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

    BENT AND GOUGED. CASE TYPE: NO ASSOCIATED PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1051119 BENT HOHMANN RETRACTOR STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 42224 00848486031909

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization