BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMAL FEMORAL NAIL ANTIROTATION Ø10 130° L240 TAN

    MDR report key: 3183239 · Received June 21, 2013

    Report

    Report Number
    2520274-2013-03668
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    May 24, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO A DEVICE MARKETED IN THE UNITED STATES. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND A LOT NUMBER WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE DEVICE HISTORY RECORDS REPORT STATES THAT THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE WAS NOT RECEIVED. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS PREVIOUSLY REPORTED ON FOLLOW UP # 1 AND SUBMITTED TO FDA ON 8/21/2013. AS THE DEVICE WAS NOT RETURNED, NO FURTHER EVALUATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT EXPERIENCED POST OP BREAKAGE OF A PROXIMAL FEMORAL NAIL ANTIROTATION AT THE LEVEL OF DISTAL LOCKING HOLE. THE BOLT IS REMAINS INTACT. THE DEVICE WAS IMPLANTED 4/12/2013. AFTER IMPLANT REMOVAL ON (B)(6) 2013, RE-OSTEOSYNTHESIS WAS PERFORMED WITH A LONG PFNA 12 MM 420 MM LENGTH. THIS IS REPORT 1 OF 1 FOR COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282459 PROXIMAL FEMORAL NAIL ANTIROTATION Ø10 130° L240 TAN NAIL, FIXATION, BONE JDS SYNTHES GMBH 7941989

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention