BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEPHALOMEDULLARY TARGETING GUIDE STANDARD

    MDR report key: 16701656 · Received April 7, 2023

    Report

    Report Number
    0001822565-2023-00961
    Event Type
    Malfunction
    Date Received
    April 7, 2023
    Date of Event
    February 17, 2023
    Report Date
    August 31, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSB
    PMA / PMN Number
    K091566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: ¿PLACEMENT OF THE CEPHALIC PIN IN THE CENTER OF THE HEAD, IN THE CENTER OF THE NECK. MEASUREMENT AT THE 115M BOREHOLE LENGTH. INSERTION OF A CERVICAL SCREW LENGTH 115 AND TWO DISTAL SCREWS USING THE AUTOMATIC ANCILLARY, THE CEPHALIC SENSATION, THE NAIL AND ITS GUIDE GOES UP OUTSIDE THE PATIENT, THE CEPHALIC SCREW HAVING PASSED IN FRONT OF THE NAIL AND NOT INSIDE OF IT. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THE REPORTED EVENT IS CONFIRMED THROUGH MEDICAL RECORDS 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). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2023-00959, 0001822565-2023-00960. CONCOMITANT MEDICAL PRODUCTS: 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD CAT: 47248403250 LOT: 65613735. 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD CAT: 47248404550 LOT: 65378233. UNKNOWN TARGETING JIG. CMN FEMORAL NAIL, CCD 125°, RIGHT, ø 11.5 MM, 21.5 CM CAT: 47249321011 LOT: 3143338. ZNN¿¢, CMN LAG SCREW, ø 10.5 MM, 115 MM INCLUDING SET SCREW CAT: 47248511510 LOT: 3093322. FOREIGN: FRANCE. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED. PRODUCT NOT RETURNED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SURGEON WAS IMPLANTING A PERITROCHANTERIC NAIL, AFTER SPEAKING WITH THE CONTROL TEAM DURING THE OPERATION, IT WAS NOTED THAT THE SCREWS HAD BEEN IMPLANTED ABOVE THE NAIL HOLES. THE NAIL WAS REMOVED AND REPLACED WITH ANOTHER BACK UP PRODUCT DURING THE SAME SURGERY. THE SURGEON IS CONCERNED THAT THE TARGETING INSTRUMENT HAD CONTRIBUTED TO THE FAILURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    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
    1785206 CEPHALOMEDULLARY TARGETING GUIDE STANDARD TRAUMA, INSTRUMENT HSB ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male SEE H10