BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALPS MIS DRILL GUIDE LK 2.7MM

    MDR report key: 7206858 · Received January 19, 2018

    Report

    Report Number
    0001825034-2018-00284
    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
    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 · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: 214227160, 2.7X160MM CALIBRATED DRILL STE, UNKNOWN. 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.

    Additional Manufacturer Narrative · 1

    (B)(4) CONCOMITANT MEDICAL PRODUCTS: 214227160, 2.7 X 160 MM CALIBRATED DRILL STE, UNKNOWN. (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- 00367.

    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.

    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
    50861 ALPS MIS DRILL GUIDE LK 2.7MM PLATE, FIXATION HRS ZIMMER BIOMET, INC. N/A 210790

    Patients

    Seq Age Sex Outcome Treatment
    1