BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9MM TI CANNULATED TIBIAL NAIL-EX/375MM-STERILE

    MDR report key: 5346387 · Received January 6, 2016

    Report

    Report Number
    1719045-2016-10019
    Event Type
    Injury
    Date Received
    January 6, 2016
    Report Date
    December 15, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDS
    PMA / PMN Number
    PK040762
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURING LOCATION: MONUMENT. MANUFACTURING DATE: SEPTEMBER 05, 2012. EXPIRATION DATE: JULY 31, 2021. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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. A PRODUCT DEVELOPMENT EVALUATION WAS PERFORMED FOR THE SUBJECT DEVICE (PART NUMBER 04.004.355S, LOT NUMBER 7020628, TI CANNULATED TIBIAL NAIL). THE NAIL WAS RECEIVED BROKEN INTO TWO PIECES AT THE FOURTH HOLE FROM THE DISTAL TIP. NO VISUAL EVIDENCE EXISTS THAT A SCREW WAS IMPLANTED IN THIS HOLE. THERE ARE VARIOUS DISCOLORATIONS AND WEAR EVIDENT ALONG THE SHAFT OF THE DEVICE. ALL OF THEM ARE CONSISTENT WITH BEING IMPLANTED AND THEN REMOVED. THE NAILS AND SCREWS ARE PART OF THE TITANIUM CANNULATED TIBIAL NAIL SYSTEM AND THEIR PROPER USE AND MAINTENANCE FOR THE DEVICE(S) ARE ADDRESSED IN TECHNIQUE GUIDE. THE SUBJECT DEVICE DRAWING WAS REVIEWED. NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED. THE DESIGN WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. AS PREVIOUSLY REPORTED, A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE EXACT CAUSE OF THE COMPLAINT CONDITION COULD NOT BE DETERMINED; THE DAMAGE TO THE NAIL APPEARS TO BE THE RESULT OF CYCLIC/EXCESSIVE LOADING. IT IS LIKELY THAT THE IMPLANT WAS BEARING THE BULK OF THE LOAD AND FINALLY FAILED FOLLOWING OVER 12 MONTHS OF BEING IMPLANTED. 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 TIBIAL NAIL WAS BROKEN. ON (B)(6) 2013, A MALE PATIENT WAS IMPLANTED WITH A TIBIAL NAIL AND THREE SCREWS. SUBSEQUENTLY, ON AN UNSPECIFIED DATE, THE PATIENT WAS WALKING AND HEARD A POP SOUND. IT WAS DETERMINED THAT THE NAIL HAD BROKEN INTO TWO PIECES, JUST ABOVE THE MOST PROXIMAL HOLE OF THE NAIL. IT IS UNKNOWN IF THE HOLE OF THE NAIL WAS OCCUPIED WITH A SCREW. ON (B)(6) 2015 THE NAIL AND THREE SCREWS WERE REMOVED AND THE PATIENT WAS REVISED WITH A NON-SYNTHES EXPANDING NAIL AND SYNTHES PLATE. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON JANUARY 18, 2016. THE PREVIOUSLY REPORTED NAIL AND SCREWS WERE RECEIVED BY SYNTHES FOR EVALUATION. THE THREE PREVIOUSLY UNKNOWN SCREWS ARE 4.0MM TITANIUM LOCKING SCREWS. THERE WAS NO ALLEGATION OF COMPLAINT AGAINST THE SCREWS. THE REPORTED NAIL WAS RECEIVED IN TWO PIECES, BROKEN AT THE FOURTH DISTAL HOLE. THERE IS NO EVIDENCE TO SUGGEST THAT A SCREW WAS IMPLANTED AT THIS HOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7985 9MM TI CANNULATED TIBIAL NAIL-EX/375MM-STERILE NAIL, FIXATION, BONE JDS SYNTHES MONUMENT 7020628

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention