BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAIL, FIXATION, BONE

    MDR report key: 5433633 · Received February 12, 2016

    Report

    Report Number
    2520274-2016-11014
    Event Type
    Malfunction
    Date Received
    February 12, 2016
    Date of Event
    February 14, 2004
    Report Date
    January 19, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    JDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS REPORT IS FOR AN UNKNOWN BOLT/UNKNOWN LOT/QUANTITY OF 1. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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 FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, FANKHAUSER, F., SEIBERT, F.J., BOLDIN, C., SCHATZ, B., AND LAMM, B. (2004). THE UNREAMED INTRAMEDULLARY TIBIAL NAIL IN TIBIAL SHAFT FRACTURES OF SOCCER PLAYERS: A PROSPECTIVE STUDY. KNEE SURG SPORTS TRAUMATOL ARTHROSC. 12: 254¿258. AUSTRIA AND US ARTICLE. TWENTY-FIVE MAINLY RECREATIONAL SOCCER PLAYERS WHO SUSTAINED A TIBIAL SHAFT FRACTURE WERE TREATED WITH THE SYNTHES UTN (UNREAMED TIBIAL NAIL). THIS PROSPECTIVE SERIES INCLUDED 25 MALES WITH A MEAN AGE OF 28.1 YEARS. DURING A MEAN PERIOD OF 4.7 YEARS (RANGE 2.8¿8.3) CLINICAL AND RADIOGRAPHIC COMPLICATIONS WERE FOLLOWED IN A PROSPECTIVE FASHION. STATIC PROXIMAL LOCKING BOLTS WERE IMPLANTED IN 14 PATIENTS, WHILST 11 PATIENTS HAD DYNAMIC INTERLOCKING BOLTS IMPLANTED. RADIOGRAPHIC COMPLICATIONS WERE OBSERVED IN FIVE PATIENTS. BREAKAGE OF INTERLOCKING BOLTS (SECONDARY DYNAMISATION) BEFORE OSSEOUS UNION OCCURRED IN FIVE PATIENTS. AT THE FINAL FOLLOW-UP VISIT 20 PATIENTS COMPLETED AN OUTCOMES-BASED QUESTIONNAIRE. THIS INDICATED THAT FIVE PATIENTS STILL HAD INTERMITTENT PAIN IN THE AREA OF THE HEALED FRACTURE, FOUR HAD CHRONIC ANTERIOR KNEE PAIN DIRECTLY OVER THE ENTRY POINT OF THE NAIL, AND ONE IN THE UPPER ANKLE JOINT (THIS PATIENT HAD AN ADDITIONAL FRACTURE OF THE LATERAL MALLEOLUS). THIS REPORT IS FOR AN UNKNOWN LOCKING BOLT AND A MALE PATIENT WHO EXPERIENCED BREAKAGE OF INTERLOCKING BOLTS (SECONDARY DYNAMISATION) BEFORE OSSEOUS UNION. THIS IS REPORT 9 OF 10 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91116 NAIL, FIXATION, BONE JDS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1