BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5972164 · Received September 22, 2016

    Report

    Report Number
    2520274-2016-14619
    Event Type
    Injury
    Date Received
    September 22, 2016
    Report Date
    September 7, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. BMI IS (B)(6), PATIENT ID:(B)(6). THIS REPORT IS FOR (1) ONE UNKNOWN CONDYLAR PLATE (POSSIBLE PART NUMBERS 222.660 OR 02.001.320) IMPLANT DATE: IN (B)(6) 2016. THE PRODUCTS WERE DISCARDED BY THE HOSPITAL AND NO LONGER AVAILABLE FOR INVESTIGATION. 510: THIS REPORT IS FOR (1) ONE UNKNOWN CONDYLAR PLATE (POSSIBLE PART NUMBERS 222.660 OR 02.001.320). (POSSIBLE PMA/510(K) NUMBERS K000066 OR K041911). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A PLATE AND ELEVEN (11) SCREWS IN (B)(6) 2016 AT ANOTHER FACILITY FOR A RIGHT DISTAL FEMUR FRACTURE. THE PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2016 FOR REVISION SURGERY DUE TO A NON-UNION OF THE RIGHT DISTAL FEMUR. DURING REVISION SURGERY, IT WAS NOTED THAT THE HEAD OF THE PLATE HAD BROKEN AND TWO (2) 5.0MM LOCKING SCREWS HAD BROKEN HEADS. THE BROKEN SCREWS WERE LOCATED AT THE SHAFT OF THE PLATE, PROXIMAL TO THE PLATE. THE PATIENT WAS GOING TO BE REVISED TO ANOTHER PLATE AND SCREW CONSTRUCT THAT WOULD HAVE BEEN PLACED ON THE MEDIAL SIDE, WHEN IT WAS NOTED THAT THE PATIENT HAD DEVELOPED AN INFECTION. THE PLATE AND ELEVEN (11) SCREWS WERE REMOVED. ONCE THE BROKEN PLATE WAS REMOVED, THE SCREW SHAFTS WERE PROMINENT AND EASILY REMOVED. THERE WAS NO SURGICAL DELAY AND STANDARD X-RAYS WERE TAKEN. THE PATIENT WAS IMPLANTED WITH AN ANTIBIOTIC SPACER IN THE NON-UNION SITE AND WAS REVISED TO AN EX-FIX BECAUSE OF THE NON-UNION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ONCE THE INFECTION RESOLVES, THE PATIENT WILL RETURN TO THE OR TO BE REVISED TO A PLATE AND SCREW CONSTRUCT. THIS REPORT IS FOR (1) ONE UNKNOWN CONDYLAR PLATE (POSSIBLE PART NUMBERS 222.660 OR 02.001.320). THIS REPORT IS 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622029 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention