BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A.L.P.S.CALIBRATED DRILL

    MDR report key: 7262669 · Received February 11, 2018

    Report

    Report Number
    0001825034-2018-00687
    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
    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 · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. BOTH RETURNED DRILL BITS WERE FOUND CONFORMING WHERE MEASURED. 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

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE ALSO SEE ASSOCIATED REPORT(S): 0001825034- 2018- 00278, 0001825034 - 2018 - 00686, 0001825034- 2018- 00279. 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

    (B)(4).

    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
    105882 A.L.P.S.CALIBRATED DRILL BIT, DRILL HTW ZIMMER BIOMET, INC. N/A 068029

    Patients

    Seq Age Sex Outcome Treatment
    1