BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN GUIDE WIRE

    MDR report key: 16406735 · Received February 21, 2023

    Report

    Report Number
    0009613350-2023-00069
    Event Type
    Malfunction
    Date Received
    February 21, 2023
    Date of Event
    December 19, 2022
    Report Date
    April 6, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HSB
    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. NO PRODUCTS WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD FOR THE UNKNOWN GUIDE WIRE CANNOT BE PERFORMED DUE TO MISSING PRODUCT IDENTIFICATION (REF AND LOT). 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 PRODUCTS- ZNN¿, CMN LAG SCREW, Ø 10.5 MM, 95 MM INCLUDING SET SCREW, ITEM# 47-2485-095-10, LOT# 3112405. REPORT SOURCE ¿ FOREIGN ¿ CANADA. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350-2023-00068. 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
    1317877 UNKNOWN GUIDE WIRE TRAUMA INSTRUMENT HSB ZIMMER SWITZERLAND MANUFACTURING GMBH N/A UNKNOWN

    Patients

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