BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 105MM-STERILE

    MDR report key: 4791605 · Received May 22, 2015

    Report

    Report Number
    3003506883-2015-10085
    Event Type
    Injury
    Date Received
    May 22, 2015
    Date of Event
    May 4, 2015
    Report Date
    May 4, 2015
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    PK011857
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). PATIENT WEIGHT IS REPORTED AS (B)(4). ADDITIONAL PRODUCT CODES FOR THIS REPORT INCLUDE HWC. (EXPIRY DATE): FEBRUARY, 2024. DEVICE WAS NOT IMPLANTED OR EXPLANTED DURING THE PROCEDURE. PER FACILITY, COMPLAINANT PARTS WILL NOT BE RETURNED FOR MANUFACTURING REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY REVIEW: MANUFACTURING DATE: (B)(6), 2015 ¿ EXPIRY DATE: FEBRUARY 2024 A REVIEW OF THE DEVICE HISTORY RECORD (DHR) REVEALED NO COMPLAINT RELATED ANOMALIES. THE DHR SHOWS LOT 7953471 (11.0MM TI HELICAL BLADE) WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NON-CONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE 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

    IT WAS REPORTED THAT A CONNECTING SCREW BROKE AND THE HELICAL BLADE WOULD NOT FULLY ADVANCE THROUGH A NAIL DURING A TROCHANTERIC FIXATION NAIL (TFN) OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE OF THE RIGHT HIP. UPON INSERTION OF THE NAIL, THE CONNECTING SCREW, WHICH ATTACHES THE NAIL TO THE INSERTION HANDLE, BROKE OFF LEAVING PART OF THE THREADS IN THE NAIL. THE REMAINING THREADED PORTION OF THE SCREW WAS REMOVED AND THE NAIL WAS TAKEN OUT AND WAS RE-ATTACHED TO THE INSERTION HANDLE WITH A DIFFERENT CONNECTING SCREW. THE NAIL WAS RE-IMPLANTED AND THE GUIDE WIRE WAS POSITIONED FOR THE HELICAL BLADE. THE HELICAL BLADE WOULD ONLY ADVANCE HALF-WAY THROUGH THE NAIL; THE LOCKING MECHANISM HAD MIGRATED DISTALLY, BLOCKING THE HELICAL BLADE FROM PASSING THROUGH THE NAIL. THE HELICAL BLADE AND THE NAIL WERE REMOVED. A NEW HELICAL BLADE AND A NEW NAIL WERE INSERTED. THERE WAS AN APPROXIMATE THIRTY (30) MINUTE SURGICAL DELAY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335750 11.0MM TI HELICAL BLADE 105MM-STERILE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES ELMIRA 7953471

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention