BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAIL, FIXATION, BONE

    MDR report key: 4109065 · Received September 23, 2014

    Report

    Report Number
    2520274-2014-13706
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    April 15, 2014
    Report Date
    September 3, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS LU, C.-C. ET AL (2014) COMPLICATIONS AND TECHNICAL PITFALLS OF TITANIUM ELASTIC NAIL FIXATION FOR MIDCLAVICULAR FRACTURES. ORTHOPEDICS 37(4), E377-E383. THIS REPORT IS FOR AN UNKNOWN TITANIUM ELASTIC NAIL. DEVICE CODE IS FOR: 1 PATIENT WITH MISPLACED NAIL INSERTION THAT REQUIRED REVISION DUE TO MINIMAL USE OF X-RAYS DURING IMPLANTATION, 2 PATIENTS W IATROGENIC PERFORATION OF THE POSTEROLATERAL CORTEX WITH NO REPORTED PRODUCT PROBLEM,1 PATIENT WITH IATROGENIC PERFORATION OF THE POSTEROLATERAL CORTEX WITH ENTRY POINT PAIN AND MEDIAL NAIL TIP PROMINENCE WITH IMPLANT REMOVAL, AND 7 PATIENTS WITH IMPLANT REMOVAL. 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 JOURNAL ARTICLE: LU, C.-C. ET AL (2014) COMPLICATIONS AND TECHNICAL PITFALLS OF TITANIUM ELASTIC NAIL FIXATION FOR MIDCLAVICULAR FRACTURES. ORTHOPEDICS 37(4), E377-E383. FROM JANUARY 2007 TO APRIL 2008, 27 PATIENTS (17 MEN, 10 WOMEN; MEAN AGE 45.8 YEARS; RANGE 16.5-66.9 YEARS) WITH MARKED DISPLACED MIDCLAVICULAR FRACTURES UNDERWENT FIXATION WITH TITANIUM ELASTIC NAILS (SYNTHES, (B)(4)). NO INFECTION, NONUNION, NAIL DISLOCATION, OR IMPLANT BREAKAGE OCCURRED AND ALL PROCEDURES HEALED WITHOUT SECONDARY PROCEDURES. A (B)(6) YEAR OLD MALE REQUESTED IMPLANT REMOVAL BUT THE IMPLANT COULD NOT BE REMOVED UNDER GENERAL ANESTHESIA SO THE PROTRUDING TIP OF THE NAIL HAD TO BE CUT. THIS IS REPORT 1 OF 4 FOR (B)(4). THIS COMPLAINT IS FOR AN UNKNOWN TITANIUM ELASTIC NAIL. A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS REPORT IS FOR 1 DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591562 NAIL, FIXATION, BONE JDS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention