BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.9MM TI LOCKING BOLT 40MM

    MDR report key: 6440295 · Received March 28, 2017

    Report

    Report Number
    3009417901-2017-10007
    Event Type
    Injury
    Date Received
    March 28, 2017
    Report Date
    March 8, 2017
    Manufacturer
    SYNTHES SALZBURG
    Product Code
    JDS
    PMA / PMN Number
    K970733
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL CODES: HTY, JDW, JDN, HSB. (B)(4). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. MANUFACTURING LOCATION: SYNTHES (B)(4). MANUFACTURE DATE: FEBRUARY 6, 2015. EXPIRATION DATE: JANUARY 1, 2025. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT IS REPORTED A PATIENT WITH BONE FRAGILITY WAS IMPLANTED WITH A PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) ON (B)(6) 2017 TO REPAIR A TROCHANTERIC AND INTERTROCHANTERIC FRACTURE OF THE FEMUR. IT IS FURTHER REPORTED THAT, POST-OPERATIVELY, AS PATIENT POSTURE WAS BEING CHANGED, THE BONE REFRACTURED AGAIN IN THE SAME LOCATION. PATIENT WAS RETURNED TO SURGERY AND REVISED ON (B)(6) 2017 DUE TO THE REFRACTURE. THE PFNA AND A 4.9MM BOLT WERE EXPLANTED. IT IS NOT KNOWN WHAT HARDWARE PATIENT WAS REVISED TO. REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) 4.9MM LOCKING BOLT. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222721 4.9MM TI LOCKING BOLT 40MM NAIL,FIXATION,BONE JDS SYNTHES SALZBURG 5932905

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention