BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE

    MDR report key: 5255023 · Received November 30, 2015

    Report

    Report Number
    2520274-2015-17529
    Event Type
    Injury
    Date Received
    November 30, 2015
    Report Date
    November 10, 2015
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    PK011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: (B)(4). DHR REVIEW ¿ PART NUMBER: 456.360S. LOT NUMBER: 7790259. RAW MATERIAL NUMBER: (B)(4). MANUFACTURE DATE: 09/19/14. EXPIRATION DATE: 08-01-2023. A REVIEW OF DEPUY SYNTHES MONUMENT DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO ISSUES. 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). 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 NARRATIVE: PATIENT INFORMATION NOT PROVIDED BY REPORTER. ADDITIONAL PRODUCT CODE ¿ HWC. (B)(4). UNKNOWN WHEN DEVICE WAS ORIGINALLY IMPLANTED. DEVICE IS SCHEDULED TO BE EXPLANTED ON (B)(6) 2015. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED 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. MFR DATE: UNKNOWN. 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

    ADDITIONAL INFORMATION ¿PATIENT WAS IMPLANTED WITH A TROCHANTERIC FIXATION NAIL (TFN), HELICAL BLADE AND TWO (2) 5.0MM LOCKING SCREWS ON AN UNKNOWN DATE. PATIENT DEVELOPED A NON-UNION AND THE NAIL AND HELICAL BLADE WAS REMOVED ON (B)(6) 2015. THE DISTAL 5.0MM LOCKING SCREWS (QUANTITY OF 2) HAD BEEN PREVIOUSLY REMOVED ON AN UNKNOWN DATE AS PART OF A PLANNED PROCEDURE FOR NAIL DYNAMIZATION. THERE WAS NO ISSUE NOTED WITH THE LOCKING SCREWS. THE NAIL AND HELICAL BLADE WERE REMOVED SUCCESSFULLY, WITHOUT ISSUE. IT WAS NOTED THAT THERE WAS NO HARDWARE BREAKAGE, LOOSENING OR MIGRATION. THERE WAS NO REPORTED SURGICAL DELAY. PATIENT WAS REVISED TO A LARGER DIAMETER NAIL AND A SHORTER HELICAL BLADE. THE DISTAL LOCKING SCREWS WERE PREVIOUSLY REMOVED AS PART OF A PLANNED NAIL DYNAMIZATION PROCEDURE. THERE WAS NO REPORTED ISSUE WITH THE TWO LOCKING SCREWS. ALTHOUGH LOCKING SCREWS WERE REMOVED PRIOR TO THE REMOVAL OF THE HELICAL BLADE AND NAIL, IT IS UNKNOWN AS TO WHEN THE NON-UNION DEVELOPED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A TROCHANTERIC FIXATION NAIL (TFN), HELICAL BLADE AND TWO (2) 5.0MM LOCKING SCREWS ON AN UNKNOWN DATE. PATIENT IS SCHEDULED FOR REMOVAL OF THE NAIL (B)(6) 2015 DUE TO A NON-UNION AND WILL BE REVISED TO ANOTHER TFN. THIS IS REPORT 2 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785890 11.0MM TI HELICAL BLADE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES ELMIRA 7585608

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention