BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 6863659 · Received September 13, 2017

    Report

    Report Number
    2520274-2017-12263
    Event Type
    Injury
    Date Received
    September 13, 2017
    Report Date
    August 22, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER UDI: (01) UNKNOWN (10) LOT NUMBER UNKNOWN. UDI UNAVAILABLE THIS REPORT IS FOR UNKNOWN SCREW LOCKING/UNKNOWN LOT NUMBER. THE NAIL AND SCREWS WERE IMPLANTED ON AN UNKNOWN DATE AT ANOTHER FACILITY. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT DEVICES REPORTED: THERAPY DATES ARE UNKNOWN. TITANIUM CANNULATED RETROGRADE/ANTEGRADE FEMORAL NAIL (PART #: 04.013.656S, LOT #: 7942218, QTY.1) UNKNOWN 5.0 MM LOCKING SCREWS (PART #: 04.005.5XX, LOT #: UNKNOWN, QTY. 2). THE 510K#: UNKNOWN. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED. BASED ON THE INFORMATION AVAILABLE, THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 THE PATIENT UNDERWENT REVISION OF A NAIL AND FOUR LOCKING SCREWS ON (B)(6) 2017 DUE TO KNEE PAIN, MIDSHAFT FEMUR NONUNION, AND TWO BROKEN SCREWS. THE NAIL AND SCREWS WERE IMPLANTED ON AN UNKNOWN DATE AT ANOTHER FACILITY. THE PATIENT ALSO HAD A TOTAL KNEE REPLACEMENT ON AN UNKNOWN DATE AT ANOTHER FACILITY. ON AN UNKNOWN DATE POSTOPERATIVELY, IT WAS DISCOVERED THAT THE TWO DISTAL LOCKING SCREWS WERE BROKEN. THE NAIL AND TWO PROXIMAL LOCKING SCREWS WERE REMOVED; THE TWO BROKEN DISTAL LOCKING SCREWS WERE LEFT IN THE PATIENT AS THE SURGEON ATTEMPTED BUT WAS UNABLE TO REMOVE THEM. IT WAS NOTICED AFTER THE SURGERY WHEN TRYING TO TAKE EVERYTHING APART THAT THE EXTRACTION SCREW WAS BENT MIDSHAFT. THE BENT BOLT HAD NO EFFECT ON THE SURGERY. THE PATIENT WAS REVISED TO A 16 HOLE VARIABLE ANGLE (VA) LOCKING COMPRESSION PLATE (LCP) CONDYLAR PLATE, NINE 5.0 MM VA LOCKING SCREWS AND SIX 4.5 MM CORTEX SCREWS. THE TOTAL KNEE REPLACEMENT MADE THE REVISION SURGERY DIFFICULT; THE SURGERY LASTED APPROXIMATELY FIVE HOURS DURING WHICH THERE WERE UNANTICIPATED X-RAYS. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH GOOD PATIENT OUTCOME. THIS COMPLAINT INVOLVES TWO (2) DEVICES: UNKNOWN 5.0 MM LOCKING SCREWS WITH ONE PART DATA. CONCOMITANT DEVICES REPORTED: TITANIUM CANNULATED RETROGRADE/ANTEGRADE FEMORAL NAIL (PART #: 04.013.656S, LOT #: 7942218, QTY. 1), UNKNOWN 5.0 MM LOCKING SCREWS (PART #: 04.005.5XX, LOT #: UNKNOWN, QTY. 2). THIS REPORT IS 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642959 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention