BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALPS MIS DRILL GUIDE LK 2.7MM

    MDR report key: 7206962 · Received January 19, 2018

    Report

    Report Number
    0001825034-2018-00281
    Event Type
    Malfunction
    Date Received
    January 19, 2018
    Date of Event
    December 18, 2017
    Report Date
    April 26, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRS
    PMA / PMN Number
    PK132898
    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: 214227160, 2.7 X 160 MM CALIBRATED DRILL STE, 937480. (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: 0001825034-2018-00280.

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE DRILL BIT IS STUCK IN THE DRILL GUIDE. THIS COMPLAINT IS THEREFORE CONFIRMED. THE OUTER DIAMETER OF THE DRILL WAS MEASURED AND FOUND TO BE IN CONFORMANCE WITH SPECIFICATIONS. IT WAS NOT POSSIBLE TO MEASURE THE INNER DIAMETER OF THE GUIDE, DUE TO THE PRESENCE OF THE DRILL. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY A ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 856135034, 3.5X34MM CORT LOCK SCR STE, LOT 929710; PRODUCT ID: 856135038, 3.5X38MM CORT LOCK SCR STE, LOT 060760; PRODUCT ID: 856135038, 3.5X38MM CORT LOCK SCR STE, LOT 109440; PRODUCT ID: 856135040, 3.5X40MM CORT LOCK SCR STE, LOT 579480; PRODUCT ID: 110016972, MIS CALC PLT SM LT STE, LOT 945040. 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 DRILL 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
    49138 ALPS MIS DRILL GUIDE LK 2.7MM PLATE, FIXATION HRS ZIMMER BIOMET, INC. N/A 047790

    Patients

    Seq Age Sex Outcome Treatment
    1