BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALPS MIS DRILL GUIDE LK 2.7MM

    MDR report key: 7262667 · Received February 11, 2018

    Report

    Report Number
    0001825034-2018-00686
    Event Type
    Malfunction
    Date Received
    February 11, 2018
    Date of Event
    December 17, 2017
    Report Date
    April 16, 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

    MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE ALSO SEE ASSOCIATED REPORT(S): 0001825034- 2018- 00278, 0001825034- 2018- 00279, 0001825034 - 2018 - 00687. CONCOMITANT MEDICAL PRODUCTS: 110008317 ALPS MIS DRILL GUIDE LK 2.7MM LOT 210790 (QUANTITY 2), 214227160 2.7X160MM CALIBRATED DRILL STE, LOT UNKNOWN, 214227160 A.L.P.S.CALIBRATED DRILL, LOT UNKNOWN, 110016972 MIS CALC PLT SM LT STE 159330, 851235050 3.5X50MM LOW PRO CORT SCR STE 479540, 856135030 3.5X30MM CORT LOCK SCR STE 773130, 856135032 3.5X32MM CORT LOCK SCR STE 018990, 856135050 3.5X50MM CORT LOCK SCR STE 125760, 856135050 3.5X50MM CORT LOCK SCR STE 841550. FOREIGN. THE EVENT OCCURRED IN THE (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. ONE OF THE TWO DRILL GUIDES FAILED DIMENSIONAL ANALYSIS OF THE INNER DIAMETER, ALTHOUGH IT IS INCONCLUSIVE WHETHER THE OBSERVED BLOCKAGE WAS DUE TO DAMAGE FROM USE OR FROM MANUFACTURING. THE OTHER GUIDE COULD NOT BE DIMENSIONALLY ANALYZED AS THE DRILL REMAINED STUCK IN THE GUIDE. 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.

    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
    105915 ALPS MIS DRILL GUIDE LK 2.7MM PLATE, FIXATION, BONE HRS ZIMMER BIOMET, INC. N/A 210790

    Patients

    Seq Age Sex Outcome Treatment
    1