BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7X160MM CALIBRATED DRILL STE

    MDR report key: 7206860 · Received January 19, 2018

    Report

    Report Number
    0001825034-2018-00367
    Event Type
    Malfunction
    Date Received
    January 19, 2018
    Date of Event
    December 26, 2017
    Report Date
    February 28, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HTW
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 110008317, ALPS MIS DRILL GUIDE LK 2.7MM, 210790. REPORT SOURCE, FOREIGN ¿ EVENTS OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 00284.

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 110016966 MIS CALC PLT SM EXTD 2H LT STE 330460, 851235034 3.5X34MM LOW PRO CORT SCR STE 479430, 856135022 3.5X22MM CORT LOCK SCR STE 217990, 856135024 3.5X24MM CORT LOCK SCR STE 452740, 856135024 3.5X24MM CORT LOCK SCR STE 537930, 856135028 3.5X28MM CORT LOCK SCR STE 262360, 856135028 3.5X28MM CORT LOCK SCR STE 473700, 856135030 3.5X30MM CORT LOCK SCR STE 109350, 856135034 3.5X34MM CORT LOCK SCR STE 929730, 856135034 3.5X34MM CORT LOCK SCR STE 929800. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE THE DRILL WAS STUCK WITH THE GUIDE, AND THE GUIDE COULD NOT MOVE IN ANY DIRECTION. THE SURGEON USED ANOTHER DRILL AND GUIDE TO COMPLETE THE PROCEDURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50862 2.7X160MM CALIBRATED DRILL STE BIT, DRILL HTW ZIMMER BIOMET, INC. N/A NG39316

    Patients

    Seq Age Sex Outcome Treatment
    1