BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPS SHRT LG DRILL GUIDE 5 HOLE

    MDR report key: 14470363 · Received May 23, 2022

    Report

    Report Number
    0001825034-2022-01233
    Event Type
    Malfunction
    Date Received
    May 23, 2022
    Date of Event
    May 5, 2022
    Report Date
    September 8, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CPS SHORT ANCHOR PLUG 14MM ITEM# 178556, LOT# 300670. THE PRODUCT HAS BEEN RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2022-02073. D10-MEDICAL PRODUCT: UNKNOWN DRILL BIT CPS SHORT ANCHOR PLUG 14MM, ITEM 178556, LOT# 300670. VISUAL INSPECTION OF THE RETURNED GUIDE DEVICE FOUND IT TO EXHIBIT SIGNS OF REPEATED USE. OUT OF THE 10 HOLES, FIVE OF THE GUIDE HOLES WERE FOUND TO BE CONFORMING AND 5 HOLES ARE DAMAGED AND FOUND TO BE NON-CONFORMING. VERIFIED HOLES WITH GAGE PIN SET 25-1003-185-00-ZC PINS .126 AND MICROMETER 25-1005-453-00-ZZZZK. MEDICAL RECORDS WERE NOT PROVIDED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO DEVIATIONS / ANOMALIES IDENTIFIED. 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

    IT WAS REPORTED THAT A DRILL FRACTURED IN THE SHORT ANCHOR PLUG OUTRIGGER DURING SURGERY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552667 CPS SHRT LG DRILL GUIDE 5 HOLE GUIDE, SURGICAL, INSTRUMENT FZX ZIMMER BIOMET, INC. N/A 226240

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SEE H10