BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE PLATE 246 MM LENGTH 8 HOLES

    MDR report key: 6429780 · Received March 23, 2017

    Report

    Report Number
    0001822565-2017-01858
    Event Type
    Injury
    Date Received
    March 23, 2017
    Date of Event
    February 3, 2017
    Report Date
    October 19, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    HRS
    PMA / PMN Number
    PK151716
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT HAS BEEN IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT PRODUCTS:: 1.8MM STAINLESS STEEL BONE PLATE CABLE, 914MM, ITEM #: 002232-003-018, LOT #: NI. 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 FEMORAL PLATING PROCEDURE, THE CABLE HOLES IN THE PLATE WERE TOO SMALL TO ALLOW THE CABLE TO PASS. THE PLATE WAS ALREADY FIXED TO THE PATIENT WITH SCREWS AND THE SURGEON DID NOT WANT TO REMOVE IT SO HE USED CERCLAGE WIRES TO COMPLETE THE PROCEDURE. THERE WAS A 1 -2 HOUR DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210278 BONE PLATE 246 MM LENGTH 8 HOLES PLATE, FIXATION HRS ZIMMER, INC. N/A 62320940

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization