BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD, FIXATION, INTRAMEDULLARY

    MDR report key: 5632344 · Received May 4, 2016

    Report

    Report Number
    2520274-2016-12547
    Event Type
    Injury
    Date Received
    May 4, 2016
    Report Date
    April 14, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THIS REPORT IS FOR TWO (2) UNKNOWN LOCKING BOLTS. PER FACILITY, THE COMPLAINANT PARTS WILL NOT BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4) PATIENT¿S COLLAPSED FEMORAL NECK AND HEAD BONE. PMA/510K: UNKNOWN, AS SPECIFIC PART AND LOT NUMBERS FOR THE COMPLAINANT BOLTS WERE NOT PROVIDED. HOWEVER, THE LIKELY 510K (BASED ON THE TYPE OF CONSTRUCT) IS K131548. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED. 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 WAS REPORTED THAT A PATIENT WAS ORIGINALLY TREATED FOR A HIP FRACTURE WITH THE IMPLANTATION OF A TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) SYSTEM ON (B)(6) 2016. THE CONSTRUCT INCLUDED THE FOLLOWING DEVICES: ONE (1) FEMORAL NAIL, ONE (1) LAG SCREW, AND TWO (2) LOCKING BOLTS. ON AN UNKNOWN POST-OPERATIVE DATE, THE PATIENT PRESENTED WITH A COLLAPSED FEMORAL NECK AND FEMORAL HEAD BONE. AS A RESULT, THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR REVISION SURGERY ON (B)(6) 2016. DURING THE REVISION, THE SURGEON SUCCESSFULLY REMOVED ALL OF THE ORIGINAL TFNA HARDWARE WITH NO REPORTED ISSUES. THE PATIENT WAS THEN REVISED TO A DEPUY TOTAL HIP REPLACEMENT. THE PATIENT'S STATUS POST-OPERATIVELY WAS REPORTED AS STABLE. THIS REPORT IS FOR TWO (2) UNKNOWN LOCKING BOLTS. THIS REPORT IS 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284920 ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention