BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIWAY HITTING PLATE

    MDR report key: 10940182 · Received December 3, 2020

    Report

    Report Number
    3010470577-2019-07142
    Event Type
    Malfunction
    Date Received
    December 3, 2020
    Date of Event
    July 8, 2019
    Report Date
    August 8, 2019
    Manufacturer
    IN2BONES SAS
    Product Code
    FZX
    UDI-DI
    03760225717950
    PMA / PMN Number
    K173811
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH RECORD WAS REVIEWED AND FOUND TO BE COMPLIANT. UPON INSPECTION OF THE PART, WHICH WAS RETURNED TO IN2BONES, IT APPEARED TO BE BROKEN WHERE IT IS THE MOST MECHANICALLY CHALLENGED WHEN ASSOCIATED WITH THE OTHER PARTS OF THE TARGETING JIG. THIS IS THE SECOND OCCURRENCE OF ANY TYPE OF INCIDENT LINKED TO THIS INSTRUMENT SINCE THE SYSTEM WAS FIRST CLEARED IN 2018. THIS EVENT IS PROBABLY DUE TO THE RECOMMENDATIONS NOT BEING ADEQUATELY FOLLOWED. THE SURGICAL TECHNIQUE MANUAL INDEED INCLUDES A STATEMENT THAT THE TIBIAL CANAL SHOULD BE REAMED 1MM ABOVE THE DESIRED NAIL DIAMETER. IF THIS STEP IS CARRIED OUT, NO SIGNIFICANT EFFORTS ARE REQUIRED TO IMPACT THE NAIL IN PLACE. ONLY FINAL ADJUSTMENT IS TO BE MADE WITH IMPACTION ON THE HITTING PLATE. HOWEVER, IN ORDER TO LIMIT THE RISK OF MALFUNCTION WHEN SURGICAL TECHNIQUE RECOMMENDATIONS ARE NOT FOLLOWED, A CHANGE CONTROL IS BEING IMPLEMENTED TO CHANGE THE HEAT TREATMENT APPLIED ON THIS INSTRUMENT, AND TO IMPROVE ITS RESISTANCE TO BREAKAGE. THE ENGINEERING DRAWING WAS REVISED ON MAY 27, 2019. THE INSTRUMENT INVOLVED WAS MANUFACTURED BEFORE THE CHANGE IMPLEMENTATION. NO FIELD ACTION IS DEEMED NECESSARY. IN2BONES SAS WILL CONTINUE TO MONITOR AND RECORD SUCH EVENTS, IF ANY. A PREVIOUS OCCURRENCE OF A SIMILAR PROBLEM (MEDWATCH REPORT 3010470577-2019-05051) CAUSED A ONE-HOUR INCREASE IN THE SURGERY DURATION AND WAS THEREFORE REPORTED. THIS IS THE REASON WHY THIS SECOND OCCURRENCE IS ALSO REPORTED : EVEN IF IT DID NOT HAVE ANY CONSEQUENCES FOR THE PATIENT, IN2BONES CONSIDERED IT COULD LEAD TO A SIGNIFICANT INCREASE IN SURGERY DURATION IF IT WERE TO RECUR. THIS EMDR WAS INITIALLY PREPARED AND SENT TO FDA IN 2019 (COMBINED REPORT SENT ON AUGUST 08TH, 2019). A FAILURE OCCURRED IN WEBTRADER ELECTRONIC FILING SYSTEM BUT THIS WAS NOT DETECTED BY IN2BONES SAS IMMEDIATELY. IN NOVEMBER 2020, A WEBTRADER CERTIFICATE ISSUE HAS BEEN RESOLVED AND, AT THE SAME TIME, IN2BONES DISCOVERED THE MESSAGES INDICATING THE RECEPTION FAILURES OF SOME EMDRS. IN CONSEQUENCE, THESE EMDRS WERE CORRECTED AND ARE NOW BEING FILED RETROSPECTIVELY.

    Description of Event or Problem · 1

    ANKLE SURGERY: THE TRIWAY(R) TTC ARTHRODESIS SYSTEM IS INTENDED FOR USE IN TIBIOTALOCALCANEAL ARTHRODESIS AND TREATMENT OF TRAUMA TO THE HINDFOOT AND DISTAL TIBIA. EXAMPLES INCLUDE: - POST-TRAUMATIC AND DEGENERATIVE ARTHRITIS INVOLVING BOTH ANKLE AND SUBTALAR JOINTS - RHEUMATOID ARTHRITIS WITH SEVERE DEFORMITY - REVISION OF FAILED ANKLE ARTHRODESIS WITH SUBTALAR INVOLVEMENT OR WITH INSUFFICIENT TALAR BODY - REVISION OF FAILED TOTAL ANKLE ARTHROPLASTY WITH SUBTALAR INTRUSION - TALAR DEFICIENCY CONDITIONS, INCLUDING AVASCULAR NECROSIS (REQUIRING A TIBIOCALCANEAL ARTHRODESIS) - NEUROARTHROPATHY OR NEUROMUSCULAR DEFORMITY OR OTHER NEUROMUSCULAR DISEASE WITH SEVERE DEFORMITY OR INSTABILITY OF THE ANKLE, INCLUDING CHARCOT FOOT - SEVERE PILON FRACTURES WITH TRAUMA TO THE SUBTALAR JOINT - MALUNITED TIBIAL PILON FRACTURES THE IN2BONES TRIWAY(R) TTC ARTHRODESIS NAIL HAS TO BE FIXED WITH THE ASSOCIATED: TIBIAL FIXATION USING COTTER SCREWS DIAMETER 5.0MM ; TALAR FIXATION USING COTTER SCREWS DIAMETER 5.0MM ; CALCANEUS FIXATION USING COTTER SCREWS DIAMETER 5.0MM. THE ADDITION OF AN IBS" 6.5MM COMPRESSION SCREW THROUGH THE SUBTALAR JOINT AND THROUGH THE NAIL IS REQUIRED. ALL SCREWS ARE INTENDED TO BE IMPLANTED THROUGH THE NAIL THANKS TO A DEDICATED TARGETING JIG. EVENT DESCRIPTION: DURING A SURGERY WITH DR. (B)(6) THE TRIWAY HITTING PLATE BROKE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE SURGERY WAS COMPLETED SUCCESSFULLY. A PREVIOUS OCCURRENCE OF A SIMILAR PROBLEM (IN2BONES INTERNAL REFERENCE (B)(4) CAUSED A ONE-HOUR INCREASE IN THE SURGERY DURATION AND WAS THEREFORE REPORTED. THIS IS THE REASON WHY THIS SECOND OCCURRENCE IS ALSO REPORTED : EVEN IF IT DID NOT HAVE ANY CONSEQUENCES FOR THE PATIENT, IN2BONES CONSIDERED IT COULD LEAD TO A SIGNIFICANT INCREASE IN SURGERY DURATION IF IT WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1406423 TRIWAY HITTING PLATE HITTING PLATE OF A TARGETING JIG FZX IN2BONES SAS N02 00011 1802050 03760225717950

    Patients

    Seq Age Sex Outcome Treatment
    1