BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM/125 DEG TI CANN TFNA 235MM/RIGHT - STERILE

    MDR report key: 5846266 · Received August 4, 2016

    Report

    Report Number
    1719045-2016-10585
    Event Type
    Injury
    Date Received
    August 4, 2016
    Report Date
    July 14, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN. DATE OF EVENT: UNKNOWN. (B)(4). DEVICE HAS NOT BEEN REPORTED AS EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4) USED TO CAPTURE THE PATIENT¿S FEMORAL HEAD ABNORMALLY ROTATED AND THE REDUCED POSITION WAS OUT OF THE NORMAL POSITION. PART 04.037.014S, LOT: 9812491: MANUFACTURED BY SYNTHES (B)(4). RELEASE TO WAREHOUSE DATE: JUNE 09, 2016. EXPIRATION DATE: MAY 31, 2025. A NON-CONFORMANCE REPORT WAS WRITTEN FOR PART 04.037.014S / LOT: 9812491 FOR 1 PART HAVING A BURR IN THE OBLIQUE PROXIMAL SIDE. THE 1 PART WAS SCRAPPED AND 5 PCS WERE APPROVED AND RELEASED TO WAREHOUSE. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE IS A POTENTIAL ISSUE DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. RELEVANCE TO THE COMPLAINT CANNOT BE DEFINITIVELY DETERMINED UNLESS THE PART IS RETURNED FOR EVALUATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 WAS REPORTED THAT AFTER THE INITIAL PROCEDURE, THE FEMORAL HEAD WITH THE HELICAL BLADE WAS ROTATED AND HAD SLID AWAY FROM THE REDUCED POSITION. THE INITIAL PROCEDURE TOOK PLACE ON (B)(6) 2016. THE SURGEON SAID THAT HE PALPATED THE FRACTURED PART FROM THE INCISIONAL PART RIGHT AFTER INTERNAL FIXING AND CONFIRMED THAT THE FEMORAL GREATER TROCHANTER WAS CORRECTLY REDUCED BEFORE CLOSING THE SURGICAL INCISION. IT WAS NOTED THAT DURING THE PROCEDURE, THE INSERTION HANDLE WAS UNSTABLE IN SPITE OF THE LOCKING MECHANISM BEING LOCKED; THE SURGEON FELT THIS MAY HAVE LED TO THE LOCKING MECHANISM NOT CONTROLLING THE SCREW AND BLADE ROTATION SUFFICIENTLY. NO PROLONGATION OF THE SURGERY REPORTED. ONE WEEK AFTER THE SURGERY, THE FRACTURED BONE WAS SUPPOSED TO BE ATTACHING TO THE OTHER FRACTURED SITE OF THE BONE, BUT IT WAS OUT OF THE POSITION TO THE DISTAL MEDULLARY CAVITY DUE TO POSSIBLY ROTATED THE FEMORAL HEAD. THE PATIENT'S FEMORAL HEAD ABNORMALLY ROTATED AND THE REDUCED POSITION WAS OUT OF THE NORMAL POSITION. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498264 10MM/125 DEG TI CANN TFNA 235MM/RIGHT - STERILE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES MONUMENT 9812491

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention