BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIX PIN FLTD 3.2DX150MM 2 PACK

    MDR report key: 21682637 · Received March 24, 2025

    Report

    Report Number
    0009617840-2025-00009
    Event Type
    Injury
    Date Received
    March 24, 2025
    Date of Event
    February 21, 2025
    Report Date
    July 18, 2025
    Manufacturer
    ZIMMER CAS
    Product Code
    OLO
    UDI-DI
    00889024563629
    PMA / PMN Number
    K182964
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED. UPDATED: D4, H4, H5, H6. IT IS UNKNOWN WHICH ITEM/LOT NUMBER OUT OF THE FOLLOWING WAS USED DURING THE EVENT: PART NUMBER: 20-8000-000-10 LOT: 66120666. PART NUMBER: 00-5901-020-00 HEADLESS TROCAR DRILL PIN 3.2 MM DIAMETER 75 MM LENGTH LOT: 66160994 ¿ PRODUCT CODE: LXH - 510K: EXEMPT ¿ UDI : (B)(4) - MANUFACTURING DATE: JUL 20, 2023 ¿ EXPIRATION DATE: JUL 17, 2033. PART NUMBER: 20-8000-000-11 FIX PIN FLTD 3.2DX80MM 2 PACK LOT: 66120615 ¿ PRODUCT CODE: OLO - 510K: K182964 ¿ UDI : (B)(4) - MANUFACTURING DATE: OCT 11, 2023 ¿ EXPIRATION DATE: JUN 30, 2028. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. AS PER THE ANALYSIS OF THE PROVIDED X-RAY PICTURE: THERE IS A SMALL RADIODENSITY AT THE POSTERIOR CORTEX OF THE DISTAL FEMORAL DIAPHYSIS CONSISTENT WITH THE RETAINED FRACTURED PIN. SMALL RETAINED PIN FRAGMENT WITHIN THE DISTAL FEMORAL DIAPHYSIS. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES RELATED TO THE REPORTED EVENT. THE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION AVAILABLE. 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). G2 FOREIGN: CHINA IT IS UNKNOWN WHICH ITEM/LOT NUMBER OUT OF THE FOLLOWING WAS USED DURING THE EVENT: 00-5901-020-00 LOT: 66160994. 20-8000-000-10 LOT: 66120666. 20-8000-000-11 LOT: 66120615. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A 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

    AFTER SURGERY, X RAY SHOWS THE PIN FRACTURED INTO PATIENT. BECAUSE OF THE POSTOPERATIVE RESULTS AND PATIENT SATISFACTION, IT WAS COMMUNICATED TO THE PATIENT THAT THERE WOULD BE NO REVISION TO REMOVE THE FRACTURED PIN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754236 FIX PIN FLTD 3.2DX150MM 2 PACK ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO ZIMMER CAS 66120666 00889024563629

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other