BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: EXPERT TIBIAL NAIL

    MDR report key: 11582882 · Received March 29, 2021

    Report

    Report Number
    8030965-2021-02398
    Event Type
    Injury
    Date Received
    March 29, 2021
    Report Date
    March 2, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    510K: THIS REPORT IS FOR AN UNK - CONSTRUCTS: EXPERT TIBIAL NAIL/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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 · 1

    THIS REPORT IS BEING REPORTED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: UEMI R, ET AL. (2020), EARLY VERSUS DELAYED WEIGHT BEARING AFTER INTRAMEDULLARY NAILING FOR TIBIAL SHAFT FRACTURE: A MULTICENTER, PROPENSITY SCORE-MATCHED STUDY, THE TRON STUDY, INJURY, VOLUME 23:19, PAGE 1-4, (JAPAN). THE PURPOSE OF THIS MULTICENTER STUDY WAS TO ASSESS DIFFERENCES IN THE RATES OF IMPLANT FAILURE AND BONE UNION BY X-RAY EXAMINATIONS, AND WALKING ABILITY, BETWEEN AN EARLY WEIGHT-BEARING (EWB) GROUP AND A NON-WEIGHT-BEARING (NWB) GROUP FOLLOWING IMN FOR TIBIAL SHAFT FRACTURES BY A PROPENSITY SCORE-MATCHING METHOD. FROM 2014 TO 2019, 263 PATIENTS WITH TIBIA FRACTURES TREATED SURGICALLY WERE INCLUDED IN THE STUDY. THE PATIENTS WERE DIVIDED INTO 2 GROUPS, THE EARLY WEIGHT-BEARING (EWB) GROUP, IN WHICH PARTIAL WEIGHT- BEARING WALKING WITHIN 4 WEEKS WAS ENCOURAGED, AND A NON-WEIGHT-BEARING (NWB) GROUP, IN WHICH NO WEIGHT BEARING WAS ALLOWED FOR MORE THAN 4 WEEKS. TO ADJUST FOR BASELINE DIFFERENCES BETWEEN GROUPS, A PROPENSITY SCORE ALGORITHM WAS USED TO MATCH THE EWB GROUP WITH THE NWB GROUP IN A 1:1 RATIO OF 75 CASES EACH. IN THE EWB GROUP, THERE WERE 53 MALES AND 22 FEMALES WITH A MEAN AGE OF 48.8 +/- 17.8 YEARS. IN THE NWB GROUP, THERE WERE 55 MALES AND 20 FEMALES WITH A MEAN AGE OF 47.3 +/-16.5 YEARS. FIVE KINDS OF IMPLANTS WERE USED WHICH INCLUDED THE UNKNOWN SYNTHES EXPERT TIBIAL NAIL AND 4 COMPETITORS¿ DEVICES. THE RATE OF IMPLANT FAILURE, THE RATE OF BONE UNION AT 6 MONTHS AND 1 YEAR AFTER SURGERY, AND WALKING ABILITY AT THE LAST FOLLOW-UP BETWEEN THE 2 GROUPS. THE AUTHORS DID NOT SPECIFY WHICH OF THE PATIENTS RECEIVED THE SYNTHES DEVICE. THUS, COMPLICATIONS WILL BE REPORTED AS FOLLOWS: 1 PATIENT DIED AFTER THE OPERATION BECAUSE OF MYOCARDIAL INFARCTION. THIS PATIENT WAS EXCLUDED FROM THE STUDY. EWB GROUP: 20 PATIENTS HAD DELAYED UNION. 5 PATIENTS HAD NON-UNION. NWB GROUP: 1 PATIENT HAD IMPLANT FAILURE. 13 PATIENTS HAD DELAYED UNION. 3 PATIENTS HAD NON-UNION. THIS REPORT IS FOR ONE (1) UNK - CONSTRUCTS: EXPERT TIBIAL NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480586 UNK - CONSTRUCTS: EXPERT TIBIAL NAIL NAIL, FIXATION, BONE JDS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention