BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZNN¿, CMN LAG SCREW, Ø 10.5 MM, 95 MM INCLUDING SET SCREW

    MDR report key: 16406736 · Received February 21, 2023

    Report

    Report Number
    0009613350-2023-00068
    Event Type
    Malfunction
    Date Received
    February 21, 2023
    Date of Event
    December 19, 2022
    Report Date
    April 5, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HSB
    UDI-DI
    00889024298446
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B3, B4, B5, D2, D9, G1, G3, G6, H1, H2, H3, H6, H10. NO PRODUCTS WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD FOR ITEM. 47-2485-095-10 LOT. 3112405 IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. DEVICES ARE USED FOR TREATMENT. 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCT: UNKNOWN GUIDE WIRE, ITEM#: UNKNOWN, LOT#: UNKNOWN. REPORT SOURCE: FOREIGN ¿ CANADA. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0009613350-2023-00069. 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

    IT WAS REPORTED THAT THE SURGEON EXPERIENCED RESISTANCE WHEN ATTEMPTING TO SLIDE THE LAG SCREW OVER THE GUIDEWIRE. THE GUIDE WIRE WAS PUSHED INTO PATIENT'S PELVIS, BUT A CT SCAN COMPLETED THE DAY AFTER SURGERY DID NOT REVEAL ANY ABDOMINAL OR PELVIC INJURY. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1317878 ZNN¿, CMN LAG SCREW, Ø 10.5 MM, 95 MM INCLUDING SET SCREW TRAUMA PROSTHESIS HSB ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3112405 00889024298446

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose SEE H10 NARRATIVE.