BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIX FLUTED PIN 3.2 X 150 MM - STERILE

    MDR report key: 17709884 · Received September 8, 2023

    Report

    Report Number
    0009617840-2023-00016
    Event Type
    Injury
    Date Received
    September 8, 2023
    Date of Event
    August 21, 2023
    Report Date
    February 28, 2024
    Manufacturer
    ZIMMER CAS
    Product Code
    OLO
    PMA / PMN Number
    K210121
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF XRAYS. THE X-RAY IMAGE PROVIDED CONFIRMED THE PRESENCE OF A METALLIC FOREIGN BODY LOCATED IN THE FEMUR. THE SUBJECT PIN WAS RETURNED. VISUAL INSPECTION OF THE DEVICE CONFIRMED THE PIN HAD A BROKEN TIP. PER THE COMPLAINT DESCRIPTION, THE PIN'S TIP BROKE IN THE FAR FEMORAL CORTEX. THE FAR FEMORAL CORTEX IS THE SECOND CORTICAL SURFACE ENCOUNTERED WHEN DRILLING BI-CORTICALLY. DRILLING THE REFERENCES BONE BI-CORTICALLY IS THE RECOMMENDED SURGICAL TECHNIQUE. A POSSIBLE ROOT CAUSE FOR THE BROKEN REFERENCE SCREW INCLUDE ANY EXAGGERATED STRESS APPLIED ON THE SCREW. HOWEVER, THIS CANNOT BE VERIFIED WITH THE INFORMATION AVAILABLE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES 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 · 0

    (B)(4). 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.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED ONE OF THE TIPS OF THE 150MM CAS PINS BROKE OFF IN THE FAR FEMORAL CORTEX OF THE PATIENT DURING EITHER INSERTION OR REMOVAL. TIP OF THE PIN WAS FOUND USING FLUOROSCOPY. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1502134 FIX FLUTED PIN 3.2 X 150 MM - STERILE INSTRUMENT, PIN OLO ZIMMER CAS N/A 65999682

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H