BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENT HOHMANN RETRACTOR

    MDR report key: 9007946 · Received September 12, 2019

    Report

    Report Number
    3005985723-2019-00669
    Event Type
    Malfunction
    Date Received
    September 12, 2019
    Date of Event
    September 9, 2019
    Report Date
    December 11, 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

    HOHMAN RETRACTOR BADLY DAMAGED - NOT ABLE TO BE USED. CASE TYPE: TKA. PRODUCTION EVALUATION AND RESULTS: VISUAL INSPECTION: THE BENT HOHMANN RETRACTOR SHOWED SIGNS OF DAMAGE. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATES 106 DEVICE(S) WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 12MAY2016 WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 210191, LOT 253465 SHOWS 02 ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSION: THE EVENT WAS 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.

    Description of Event or Problem · 0

    HOHMAN RETRACTOR BADLY DAMAGED - NOT ABLE TO BE USED. CASE TYPE: TKA.

    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

    HOHMAN RETRACTOR BADLY DAMAGED - NOT ABLE TO BE USED. CASE TYPE: TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801697 BENT HOHMANN RETRACTOR STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 253465 00848486031909

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization