BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOLT, NUT, WASHER

    MDR report key: 5398237 · Received January 29, 2016

    Report

    Report Number
    2520274-2016-10441
    Event Type
    Malfunction
    Date Received
    January 29, 2016
    Report Date
    January 14, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HTN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REYNDERS, P. AND BROOS, P. (2000). HEALING OF CLOSED FEMORAL SHAFT FRACTURES TREATED WITH THE AO UNREAMED FEMORAL NAIL. A COMPARATIVE STUDY WITH AO REAMED FEMORAL NAIL. INJURY, INTERNATIONAL JOURNAL OF THE CARE OF THE INJURED, 367-371. THIS REPORT IS FOR AN AN UNKNOWN LOCKING BOLT THAT BROKE POSTOPERATIVELY/UNKNOWN QUANTITY/UNKNOWN LOT. (OTHER NUMBER) UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. 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. 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 THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: REYNDERS, P. AND BROOS, P. (2000). HEALING OF CLOSED FEMORAL SHAFT FRACTURES TREATED WITH THE AO UNREAMED FEMORAL NAIL. A COMPARATIVE STUDY WITH AO REAMED FEMORAL NAIL. INJURY, INTERNATIONAL JOURNAL OF THE CARE OF THE INJURED, 367-371. THIS STUDY SUMMARIZES THE CLINICAL EXPERIENCES OF HEALING TIME WITH THE UNREAMED FEMORAL NAIL (UFN) GROUP COMPARED TO THE REAMED FEMORAL NAIL (RFN) GROUP IN ONE HUNDRED AND SEVEN CLOSED FEMORAL FRACTURES. FIFTY THREE PATIENTS WERE TREATED WITH THE UFN AND FIFTY-FOUR WERE TREATED WITH THE RFN. MEAN PATIENT AGE FOR THE RFN GROUP WAS 30.7 YEARS AND 34.4 YEARS FOR THE UFN GROUP. COMPLICATIONS INCLUDED: UNKNOWN PATIENT AND AN UNKNOWN LOCKING BOLT THAT BROKE POSTOPERATIVELY WITHOUT COMPROMISING FRACTURE HEALING. THIS IS REPORT 4 OF 5 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN LOCKING BOLT. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56436 BOLT, NUT, WASHER HTN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1