BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A/R SCREW DRILL

    MDR report key: 18606387 · Received January 30, 2024

    Report

    Report Number
    0001825034-2024-00160
    Event Type
    Malfunction
    Date Received
    January 30, 2024
    Date of Event
    January 5, 2024
    Report Date
    June 4, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HTW
    UDI-DI
    00887868023484
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D4: END LEVEL LOT #¿S: 126400, 982050, 982040, 982020, 917010, 872550, 775720, 775670, 775660, 775080, 775090. EXPIRATION DATES: LOT 126400- MAR 4, 2031, LOT 982050- MAR 3, 2031, LOT 982040- MAR 10, 2031, LOT 982020- FEB 23, 2031, LOT 917010- MAR 2, 2031, LOT 872550- JAN 28, 2031, LOT 775720- JAN 27, 2031, LOT 775670- JAN 27, 2031, LOT 775660- JAN 28, 2031, LOT 775080- FEB 2, 2031, LOT 775090- FEB 11, 2031. H4: MANUFACTURING DATES: LOT 126400- MAR 4, 2021, LOT 982050- MAR 3, 2021, LOT 982040- MAR 10, 2021, LOT 982020- FEB 23, 2021, LOT 917010- MAR 2, 2021, LOT 872550- JAN 28, 2021, LOT 775720- JAN 27, 2021, LOT 775670- JAN 27, 2021, LOT 775660- JAN 28, 2021, LOT 775080- FEB 2, 2021, LOT 775090- FEB 11, 2021. THE 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H3, H6, H11 VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED ONE A/R SCREW DRILL WAS RETURNED AND THE TIP IS FRACTURED. UPON VISUAL INSPECTION THERE ARE WEAR LINES ON THE SHAFT OF THE DEVICE, INCLUDING NEAR THE FRACTURED TIP LOCATION, THAT APPEAR TO BE CONSISTENT WITH REPEATED USE OF THE DEVICE. PART AND SUPPLIER LOT NUMBER CONFIRMED FROM ETCH. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT FOR LOT 126400. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING FOR THE REMAINING LOTS. THE RETURNED DRILL, WHICH IS A SINGLE-USE INSTRUMENT, HAS MARKINGS THROUGHOUT THE PRODUCT WHICH APPEAR TO BE CONSISTENT WITH REPEATED USE. HOWEVER, PER FOLLOW UP COMMUNICATIONS, IT IS UNKNOWN IF THIS DEVICE HAS BEEN USED PREVIOUSLY. THEREFORE, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED FRACTURE EVENT IS CONFIRMED FROM PRODUCT RETURN. 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 · 0

    IT WAS REPORTED THAT THE DRILL TIP BROKE INSIDE THE PATIENT. THERE WAS NO FOREIGN BODY RETAINED. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1043346 A/R SCREW DRILL INSTRUMENT, HIP HTW ZIMMER BIOMET, INC. N/A SEE H11 00887868023484

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female