BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAIL, FIXATION, BONE

    MDR report key: 3790137 · Received May 5, 2014

    Report

    Report Number
    2520274-2014-11201
    Event Type
    Injury
    Date Received
    May 5, 2014
    Report Date
    April 9, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    JDS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. FRIGG, A., RILLMANN, P., RYF, C., GLAAB, R., REISSNER, L. (2011). CAN COMPLICATIONS OF TITANIUM ELASTIC NAILING WITH END CAP FOR CLAVICULAR FRACTURES BE REDUCED? CLIN ORTHOP RELAT RES 469:3356-3363. THIS REPORT IS FOR AN UNKNOWN TITANIUM ELASTIC NAIL. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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: CAN COMPLICATIONS OF TITANIUM ELASTIC NAILING WITH END CAP FOR CLAVICULAR FRACTURES BE REDUCED?; FRIGG, A., RILLMANN, P., RYF, C., GLAAB, R., REISSNER, L. (2011). CAN COMPLICATIONS OF TITANIUM ELASTIC NAILING WITH END CAP FOR CLAVICULAR FRACTURES BE REDUCED? CLIN ORTHOP RELAT RES 469:3356-3363. THIS STUDY INVESTIGATED WHETHER THE COMPLICATION RATE COULD BE REDUCED BY CAUTIOUS LATERAL ADVANCEMENT OF THE TITANIUM ELASTIC NAILS (TENS), INTRAOPERATIVE OBLIQUE RADIOGRAPHS TO RULE OUT LATERAL PERFORATION, AND LIMITED ROM POSTOPERATIVELY; FLUOROSCOPY TIME COULD BE REDUCED; AND SHOULDER FUNCTION WOULD BE REASONABLE. FORTY FOUR (44) PATIENTS WITH CLAVICULAR MIDSHAFT FRACTURES TREATED WITH A TEN USING AN END CAP (SYNTHES) FROM (B)(6) 2006 TO (B)(6) 2009. THERE WERE 37 MALES AND SEVEN FEMALES WITH AN AVERAGE AGE OF 31 YEARS. PATIENTS WERE DIVIDED INTO TWO GROUPS: A (FREE RANGE OF MOTION POST-OP) AND B (LIMITED RANGE OF MOTION POST-OP). COMPLICATIONS IN GROUP A WERE 4 NAIL PERFORATIONS, 1 REVISED NAIL BREAKAGE, 1 REVISED DISLOCATION, AND 3 MINOR COMPLICATIONS SUCH AS PAIN. COMPLICATIONS IN GROUP B INCLUDED 1 NAIL PERFORATION, 1 REVISED NON-UNION, 1 NAIL BUCKLING DUE TO POST-OP INJURY, AND 2 MEDIAL SKIN IRRITATIONS BY THE END CAP. THIS REPORT IS 2 OF 2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN TITANIUM ELASTIC NAIL. A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266642 NAIL, FIXATION, BONE JDS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention