BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM INSERTER LONG

    MDR report key: 7272550 · Received February 15, 2018

    Report

    Report Number
    0001825034-2018-00912
    Event Type
    Malfunction
    Date Received
    February 15, 2018
    Date of Event
    January 11, 2018
    Report Date
    June 4, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL AND CORRECTED INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. INSPECTION OF THE DEVICE IDENTIFIED A JAGGED FRACTURE AROUND THE TIP OF THE DEVICE, WITH A PORTION MISSING. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. HARDNESS TESTING OF THE DEVICE FOUND THE DEVICE TO BE IN CONFORMANCE WITH SPECIFICATIONS. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AND THE PRODUCT WAS LIKELY CONFORMING WHEN IT LEFT ZIMMER BIOMET CONTROL. 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 · 1

    (B)(6). CONCOMITANT: 40632, 10.5MMX320MM TIBIAL NAIL, 938160; 14-441281, OFFSET END CAP 11X5MM, 279510; 14-405040, TI-DBLE LEAD CORT 5.0X40MM SCR, 325230; 14-405040, TI-DBLE LEAD CORT 5.0X40MM SCR, 787360; 14-405044, TI-DBLE LEAD CORT 5.0X44MM SCR, 454180; 14-405048, TI-DBLE LEAD CORT 5.0X48MM SCR, 133280; 14-405058, TI-DBLE LEAD CORT 5.0X58MM SCR, 295320. (B)(6). 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 MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE THE TIP OF THE INSERTER WAS FRACTURED WHILE INSERTING THE END CAP INTO THE NAIL. THE FRACTURED PORTION WAS ABLE TO BE RETRIEVED FROM THE END CAP OF THE NAIL. NOTHING FELL INTO THE PATIENT, AND NO ISSUES OF THE PATIENT WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118073 3.5MM INSERTER LONG SCREWDRIVER HXX ZIMMER BIOMET, INC. N/A 326870

    Patients

    Seq Age Sex Outcome Treatment
    1