BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTION JIG 125 DEGREE 1.5M

    MDR report key: 6913564 · Received October 4, 2017

    Report

    Report Number
    0001825034-2017-07852
    Event Type
    Malfunction
    Date Received
    October 4, 2017
    Date of Event
    January 5, 2015
    Report Date
    October 3, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LHX
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT - (B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. PRODUCT LEFT CONFORMING TO PRINT AS THERE WAS NO EVIDENCE THAT STATES OTHERWISE. PER ENGINEER, ¿THE ONLY THING THAT CAN BE SAID IS THAT THEY NEED TO PUT THE A/R GUIDE IN WITH THE LAG SCREW GUIDE TUBE AS DESCRIBED ON PAGE 20 OF THE ATTACHED SURGICAL TECHNIQUE. IF THEY FOLLOW THIS TECHNIQUE THEN THEY WILL SEE THAT THERE IS RESISTANCE ON THE A/R GUIDE TUBE.¿ DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS RELATED TO SURGICAL TECHNIQUE. THE CONDITION IS ADDRESSED IN THE SURGICAL TECHNIQUE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    INSERTION JIG DESIGN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693533 INSERTION JIG 125 DEGREE 1.5M ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LHX ZIMMER BIOMET, INC. N/A CX2048C02

    Patients

    Seq Age Sex Outcome Treatment
    1