BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN SCREW

    MDR report key: 12277443 · Received August 4, 2021

    Report

    Report Number
    0001822565-2021-02195
    Event Type
    Malfunction
    Date Received
    August 4, 2021
    Date of Event
    May 23, 2021
    Report Date
    August 9, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWC
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D10; G3; G6; H1; H2; H6 D10: MEDICAL PRODUCTS: ITEM#: 00249004732, THREADED PIN 3.2 MM DIAMETER 508 MM LENGTH; LOT#: 64971171 ITEM#: 00249004732, THREADED PIN 3.2 MM DIAMETER 508 MM LENGTH; LOT#: 64971171 ITEM#: 47249321010, CMN FEMORAL NAIL, CCD 125°, RIGHT, ø 10 MM, 21.5 CM; LOT#: 3050551 ITEM#: 47248509510, ZNN¿¢, CMN LAG SCREW, ø 10.5 MM, 95 MM, INCLUDING SET SCREW; LOT#: 2959581 ITEM#: 281001175, 3.2X444MM THRD GUIDE PIN STE; LOT#: OJ1AA5A ITEM#: 47248508510, ZNN¿¢, CMN LAG SCREW, ø 10.5 MM, 85 MM, INCLUDING SET SCREW; LOT#: 3020889 NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS; NEITHER WERE PROVIDED FOR THE SCREW. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT 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 · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM#: 00249000351, CEPHALOMEDULLARY LAG SCREW RETAINER SHAFT LONG; LOT#: UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. 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 SURGICAL PROCEDURE WHILE ASSEMBLING THE IMPLANT ONTO THE INSTRUMENT, THE IMPLANT WOULD NOT FULLY ENGAGE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175812 UNKNOWN SCREW IMPLANT/TRAUMA HWC ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1