BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 6151960 · Received December 7, 2016

    Report

    Report Number
    2520274-2016-15616
    Event Type
    Injury
    Date Received
    December 7, 2016
    Report Date
    November 14, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: (B)(6). PATIENT AGE/DATE OF BIRTH ARE UNKNOWN. EVENT DATE: UNKNOWN. THIS REPORT IS FOR AN UNKNOWN 5.0MM LOCKING SCREW/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. (THERAPY DATE): UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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 WAS IMPLANTED WITH A TROCHANTERIC PROXIMAL FEMORAL NAILING SYSTEM ADVANCED (TFNA); AN UNKNOWN 5.0MM LOCKING SCREW, AND A TROCHANTERIC PROXIMAL FEMORAL NAILING SYSTEM ADVANCED (TFNA) SCREW ON (B)(6) 2015. ON AN UNKNOWN DATE, THE LOCKING SCREW CUT OUT. ON (B)(6) 2016, THE PATIENT WAS RETURNED TO THE OPERATING ROOM TO REMOVE ALL OF THE IMPLANTED DEVICES AND WAS REVISED TO A TOTAL HIP SYSTEM. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY REPORTED AND THE PATIENT WAS STABLE. CONCOMITANT DEVICE REPORTED: SCREW (PART 04.038.075, LOT 9802474, QUANTITY 1); SCREW (PART 04.037.142S, LOT 9834631, QUANTITY 1). THIS REPORT IS FOR AN UNKNOWN 5.0MM LOCKING SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804090 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 1 PART 04.037.142S, LOT 9834631, SCREW| 1 PART 04.038.075, LOT9802474, SCREW