BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5343209 · Received January 5, 2016

    Report

    Report Number
    2520274-2016-10035
    Event Type
    Injury
    Date Received
    January 5, 2016
    Date of Event
    December 15, 2015
    Report Date
    December 15, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 510(K): REPORT IS FOR TWO (2) UNKNOWN DISTAL SCREWS. UDI: PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN; UDI UNKNOWN . DEVICE REPORTEDLY IMPLANTED IN 2013; EXACT IMPLANT DATE UNKNOWN. DEVICE BROKE INTRA-OPERATIVELY AND WAS NOT FULLY EXPLANTED. 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.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 EXPERIENCED NON-UNION AND HARDWARE THAT BROKE DURING IMPLANT REMOVAL SURGERY. A PATIENT EXPERIENCED A SUBTROCHANTERIC FRACTURE OF THE LEFT FEMUR AND WAS TREATED WITH A LONG TROCHANTERIC FIXATION NAIL (TFN), LAG SCREW AND TWO DISTAL SCREWS IN 2013. SUBSEQUENTLY, THE PATIENT EXPERIENCED NON-UNION AS SEEN ON X-RAY (DATE UNKNOWN). ON (B)(6) 2015 ALL HARDWARE WAS REMOVED. A BIOPSY WAS TAKEN INTRA-OPERATIVELY TO RULE OUT OSTEOMYELITIS. DURING THE REMOVAL PROCEDURE, BOTH DISTAL SCREWS BROKE; ONLY PARTS OF THE SCREWS WERE RETRIEVED. IT WAS REPORTED THAT THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT IS SCHEDULED TO BE IMPLANTED WITH COMPETITOR DEVICES ON (B)(6) 2015. THIS REPORT ADDRESSES THE TWO (2) SCREWS THAT BROKE DURING THE EXPLANT SURGERY ON (B)(6) 2015. THE PATIENT'S NON-UNION IS REPORTED UNDER COMPLAINT: (B)(4). THIS IS REPORT 1 OF 1 FOR COM-152481.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3919 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention