BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM F/IM NAIL-STER

    MDR report key: 6366542 · Received February 28, 2017

    Report

    Report Number
    1719045-2017-10154
    Event Type
    Injury
    Date Received
    February 28, 2017
    Report Date
    February 2, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K000089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4): THE REPORT STATES THE FEMORAL HEAD COLLAPSED WHICH CAN CAUSE OR CONTRIBUTE TO THE NEED FOR MEDICAL OR SURGICAL INTERVENTION. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: DHR REVIEW FOR: MANUFACTURING LOCATION: (B)(4); MANUFACTURING DATE: 29-FEB-2016; EXPIRATION DATE: 31-JAN-2025. PART #: 04.005.524S, LOT#: H040575 (STERILE) - 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM F/IM NAIL - STERILE. QUANTITY (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. SCN 12272, ¿STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING.¿ 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 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 IS REPORTED PATIENT WAS IMPLANTED WITH THE TROCHANTERIC FEMORAL NAIL-ADVANCED AND HELICAL BLADE ON UNKNOWN DATE. SURGEON REPORTED ON (B)(6) 2017 THAT THE FEMORAL HEAD HAD COLLAPSED. PATIENT WAS REFERRED TO ANOTHER FACILITY AND SURGEON. IT IS NOT KNOWN IF PATIENT UNDERWENT A REVISION. NO FURTHER INFORMATION WAS PROVIDED. UPDATE: PATIENT WAS IMPLANTED WITH 11MM 130 DEGREE TROCHANTERIC FEMORAL NAIL-ADVANCED, 85MM HELICAL BLADE, AND ONE (1) 5.0MM LOCKING SCREW ON (B)(6) 2016. ON UNKNOWN DATE, PATIENT REPORTED PAIN. X-RAY TAKEN ON UNKNOWN DATE REVEALED THE FEMORAL HEAD HAD COLLAPSED. PATIENT WAS REFERRED TO ANOTHER UNKNOWN FACILITY FOR FOLLOW UP. IT IS NOT KNOWN IF PATIENT WAS REVISED. 2 DEVICES. THIS REPORT IS 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148283 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM F/IM NAIL-STER SCREW, FIXATION, BONE HWC SYNTHES MONUMENT H040575

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention