BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAIL, FIXATION, BONE

    MDR report key: 7196434 · Received January 16, 2018

    Report

    Report Number
    8030965-2018-50390
    Event Type
    Injury
    Date Received
    January 16, 2018
    Date of Event
    December 18, 2017
    Report Date
    December 19, 2017
    Manufacturer
    OBERDORF : SYNTHES PRODUKTIONS GMBH
    Product Code
    JDS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN. THIS REPORT IS FOR AN UNKNOWN TIBIAL NAIL/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DUE TO INTRA-OPERATIVE ISSUES, THE DEVICE WAS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). (B)(4). 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

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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

    CONCOMITANT MEDICAL PRODUCTS: INSERTION HANDLE (PART 03.010.440, LOT 170223-101, QUANTITY 1) IS NO LONGER A CONCOMITANT DEVICE. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY WHEN USING THE SUPRA PATELLA NAILING KIT, THE SURGEON WAS UNABLE TO DISCONNECT THE CONNECTING SCREW FROM THE NAIL. EVENTUALLY HE HAD TO GIVE UP ON REMOVING THE CONNECTING SCREW IN FEAR OF CAUSING MORE DAMAGE TO THE PATIENT. HE THEN HAD TO REMOVE THE LOCKING BOLTS THAT HE HAD INSERTED AND THEN REMOVE THE NAIL STILL CONNECTED TO THE INSERTION HANDLE. HE THEN USED A NON-SYNTHES TIBIAL NAIL SUPRA PATELLA AND HAD NO ISSUES. IT WAS REPORTED THERE WAS A NINETY TO ONE-HUNDRED-TWENTY (90-120) MINUTE DELAY TO THE PROCEDURE, BUT THAT THE PROCEDURE AS SUCCESSFULLY COMPLETED WITH NO HARM TO THE PATIENT. CONCOMITANT DEVICES: LOCKING SCREW (PART/LOT UNKNOWN, QUANTITY UNKNOWN); INSERTION HANDLE (PART 03.010.440, LOT 170223-101, QUANTITY 1). THIS REPORT IS FOR AN UNKNOWN TIBIAL NAIL. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38480 NAIL, FIXATION, BONE JDS OBERDORF : SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention