BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHN MULTILOC Ø8 IZQ CAN L160 TAN

    MDR report key: 14916416 · Received July 5, 2022

    Report

    Report Number
    8030965-2022-04559
    Event Type
    Malfunction
    Date Received
    July 5, 2022
    Date of Event
    June 8, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    UDI-DI
    07611819431034
    PMA / PMN Number
    K103002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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. 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 · 0

    IT WAS REPORTED ON (B)(6) 2022 THAT AT THE END OF THE INSERTION OF THE NEW NAIL, THE CLOSING CAP IS PLACED, WHICH CANNOT BE SCREWED INTO THE TIP OF THE NAIL AND WE DECIDES TO LEAVE IT WITHOUT A CAP. THE MULTILOC NAIL IS MOUNTED ON THE INSERTION HANDLE, IMPACTED AND UNIMPACTED SEVERAL TIMES. PROXIMAL LOCKS ARE PERFORMED, WHICH DO NOT MATCH THE HOLES BECAUSE THE DRILL COLLIDES WITH THE NAIL WHEN DRILLING. IT IS DECIDED TO REMOVE THE NAIL TO VERIFY CALIBRATION AND A RUPTURE IS NOTED IN THE UNION OF THE NAIL WITH THE INSERTION ARCH, ANOTHER NAIL IS PASSED. THERE WAS A SURGICAL DELAY IN RELATION TO THE REPORTED EVENT OF MORE THAN AN HOUR. PROCEDURE IS FINISHED. THIS REPORT IS FOR ONE (1) PHN MULTILOC Ø8 IZQ CAN L160 TAN. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163337 PHN MULTILOC Ø8 IZQ CAN L160 TAN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH 527P723 07611819431034

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown