BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5682375 · Received May 26, 2016

    Report

    Report Number
    2520274-2016-12860
    Event Type
    Injury
    Date Received
    May 26, 2016
    Date of Event
    April 8, 2016
    Report Date
    May 10, 2016
    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

    PLEASE SEE MAUDE REPORTS (MW#5061738 AND MW#5061739) ATTACHED TO THIS REPORT. PATIENT IDENTIFIER WAS NOT AVAILABLE FOR REPORTING. THIS REPORT IS FOR TWO UNKNOWN SCREWS. PART AND LOT NUMBERS WERE NOT AVAILABLE FOR REPORTING. OTHER NUMBER¿UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. SINCE THE COMPLAINED REVISION SCREWS BROKE DURING INSERTION, THEY MAY NOT PERFORM THEIR INTENDED FUNCTION AND ARE NOT CONSIDERED TO HAVE BEEN IMPLANTED. THE SUBJECT DEVICES ARE NOT EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION. THERAPY DATE: INITIAL IMPLANTS WERE IMPLANTED ON AN UNKNOWN DATE IN 2006 AND REVISED OR EXPLANTED ON (B)(6) 2016. 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. 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

    MAUDE REPORTS (MW#5061738 AND MW#5061739) WERE RECEIVED BY SYNTHES CUSTOMER QUALITY ON MAY 10, 2016. IT WAS REPORTED DURING AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF LEFT FEMUR TO TREAT NONUNION WITH EXCHANGE NAILING ON (B)(6) 2016, TWO UNKNOWN SCREWS BROKE DURING ATTEMPTED INSERTION. THE TIPS OF THE SCREWS REMAIN IN THE PATIENT'S FEMUR AS THE SURGEON WAS UNABLE TO REMOVE THEM. IT WAS FURTHER REPORTED THAT WHEN THE SURGEON WAS USING A REDUCTION FORCEPS ONE OF THE TIPS BROKE OFF. THE BROKEN FORCEPS PIECE WAS RECOVERED EASILY AND THERE WAS NO UNTOWARD EFFECT ON THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAYS. THIS REPORT ADDRESSES THE INTRAOPERATIVE BREAKAGE OF THE TWO REVISION SCREWS AND THE REDUCTION FORCEPS. THE INITIALLY IMPLANTED UNKNOWN DEVICES BEING REVISED AND/OR EXPLANTED DURING THE REVISION SURGERY WERE IMPLANTED ON AN UNKNOWN DATE IN 2006 AND WERE NOT REPORTEDLY MANUFACTURED BY SYNTHES. THIS REPORT IS FOR TWO UNKNOWN SCREWS. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336779 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention UNKNOWN IMPLANT DEVICES