BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA-II BLADE L85 TAN

    MDR report key: 4140138 · Received October 3, 2014

    Report

    Report Number
    9612488-2014-10424
    Event Type
    Injury
    Date Received
    October 3, 2014
    Report Date
    September 6, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    ADDITIONAL NARRATIVE: A PRODUCT INVESTIGATION WAS COMPLETED: THE DEVICE WAS RECEIVED INTACT AND NO ISSUES WERE DISCOVERED DURING INVESTIGATION. 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

    PATIENT DEVELOPED SYNOSTOSIS AND CALLUS. ADDITIONAL PRODUCT CODE: HWC. IMPLANT DATE REPORTED AS: (B)(6) 2014. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THERE ARE NO NCRS WERE GENERATED DURING PRODUCTION. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE INITIAL SURGERY OF (B)(4) CASE WAS OPERATED IN (B)(6) 2014. WHILE RECEIVING HER REHABILITATION SUPPORT, THE PATIENT COMPLAINED SUDDEN PAIN ON HER HIP JOINT AND VISITED THE FACILITY ON (B)(6) 2014. THEN IT WAS FOUND THAT THE LONG NAIL IN QUESTION WAS BROKEN. ON (B)(6), THE SURGEON RE-OPERATED PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) FOR THIS EVENT. THE SURGEON COMMENTED IT WAS SEEN A BIT OF VARUS DEFORMITY AT AROUND (B)(6). THE EXACT DATE WAS UNKNOWN, BUT APPROXIMATELY TWO WEEKS BEFORE THE BREAKAGE AND IT WAS REPORTED THAT SYNOSTOSIS AND A CALLUS OF THE PATIENT PROGRESSED SLOWLY AND WAS DISCOVERED DURING A FOLLOW-UP. THIS IS REPORT NUMBER 2 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620935 PFNA-II BLADE L85 TAN ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES BETTLACH 2700680

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention