BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHOENIX 3.5MM INSERTER SHORT

    MDR report key: 6775860 · Received August 8, 2017

    Report

    Report Number
    0001825034-2017-05892
    Event Type
    Injury
    Date Received
    August 8, 2017
    Date of Event
    July 5, 2017
    Report Date
    May 18, 2018
    Manufacturer
    BIOMET TRAUMA
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). CONCOMITANT MEDICAL PRODUCT - OFFSET END CAP 11X5MM, PART #: 14-441281, LOT #279510. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-05891, AND 0001825034-2017-05892.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. INITIAL REPORT REPORTED LOT#: 798122. HOWEVER UPON FURTHER REVIEW IT IS FOUND THAT LOT 781225 WAS ISSUED TO 3 LOT #'S: 098710, 615580 OR 843800. AS IT IS UNKNOWN WHICH LOT THIS COMPLAINT PERTAINS TO WE WILL LIST ALL THREE. LOT#: 098710, MANUFACTURE DATE: APR 19, 2017, UDI#: (B)(4). LOT#: 615580, MANUFACTURE DATE: MAR 15, 2017, UDI#: (B)(4). LOT#: 843800, MANUFACTURE DATE: MAR 30, 2017, UDI#: (B)(4). CONCOMITANT MEDICAL PRODUCT- UNKNOWN END CAP 10MM CATALOG#:UNK LOT#:UNK, OFFSET END CAP 11X5MM CATALOG#:14-441281 LOT#:311710, 3.5MM INSERTER CONNECTOR SHORT CATALOG#: 14-441045 LOT#: ZB151101. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE PRODUCT WAS RETURNED FOR EVALUATION. THE RETURNED TIP OF THE CONNECTOR IS BROKEN INTO THE END CAP. THE INSERTER TIP IS ALSO FRACTURED. PARTS ARE NOTED TO BE VISUALLY CONFORMING TO PRINT SPECIFICATIONS OTHERWISE. DUE TO THE MISSING PIECE OF THE CONNECTOR AND THE FRACTURED PART OF THE CONNECTOR ACCURATE FUNCTIONAL AND DIMENSIONAL ANALYSIS CANNOT BE PERFORMED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE FOR THE FRACTURED INSERTER WAS UNABLE TO BE DETERMINED. 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 · 1

    IT WAS REPORTED THAT DURING A TIBIA FRACTURE NAILING PROCEDURE, THAT BOTH THE INSERTER CONNECTOR AND INSERTER FRACTURED, WHICH LED TO THE REMOVAL OF THE END CAP ALREADY IMPLANTED IN THE PATIENT, AS THE INSERTER CONNECTOR REMAINED IN THE ORIGINAL END CAP. A 10MM END CAP WAS IMPLANTED WITH MINIMAL DELAY TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554715 PHOENIX 3.5MM INSERTER SHORT SCREWDRIVER HXX BIOMET TRAUMA N/A REFERENCE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention