BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM/130 DEG TI CANN TFNA 400MM/RIGHT - STERILE

    MDR report key: 5162635 · Received October 20, 2015

    Report

    Report Number
    1719045-2015-10683
    Event Type
    Injury
    Date Received
    October 20, 2015
    Report Date
    October 7, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    PK131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

    (B)(4). 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

    PATIENT DATE OF BIRTH/AGE IS UNKNOWN. DATE OF POSTOPERATIVE BREAKAGE IS UNKNOWN. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY RECORD REVIEW: MANUFACTURING LOCATION: (B)(4) ¿ MANUFACTURING DATE: APRIL 9, 2015 ¿ EXPIRATION DATE: MARCH 31, 2025. A REVIEW OF DEPUY SYNTHES (B)(4) RECORDS FOR MANUFACTURING REVEALED NO ISSUES FOR THIS DEVICE THAT WOULD RELATE TO THE 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

    UPDATE: 11/02/2015, IT WAS REPORTED THAT THE PATIENT STATUS IS GOOD POST-OPERATIVE AND THAT THE SURGERY WAS SUCCESSFULLY COMPLETED. IT WAS CORRECTED THAT THE REVISION SURGERY OCCURRED ON (B)(6) 2015.

    Description of Event or Problem · 1

    IT WAS CLARIFIED THAT A (B)(6) MALE PATIENT, 3 MONTHS POST OPERATIVELY EXPERIENCED A BREAK OF AN INTERLOCK SCREW BUT THAT THE BROKEN SCREW DID NOT CAUSE ANY PAIN. THE PATIENT PRESENTED TO THE EMERGENCY ROOM TWO DAYS AFTER X-RAYS WERE TAKEN BECAUSE OF ACUTE ONSET OF HIP PAIN EXPERIENCED WHILE FLEXING HIS HIP, GETTING INTO HIS CAR. HE REPORTEDLY DID NOT FALL. X-RAYS TAKEN AT THIS TIME INDICATE THAT THE HELICAL NAIL WAS BROKEN BUT IT WAS NOT NOTICED BY THE EMERGENCY ROOM STAFF AND THE PATIENT WAS DISCHARGED WITHOUT NOTIFYING THE ORTHOPEDIC DEPARTMENT/SURGEON. TWO DAYS AFTER HIS VISIT TO THE EMERGENCY ROOM THE PATIENT PRESENTS BACK TO THE EMERGENCY ROOM AFTER A FALL. X-RAYS DETERMINE THAT THE FRACTURE HAS ACUTE SUBTROCHANTERIC EXTENSION. X-RAYS OF INTRAOPERATIVE TRACTION ARE TAKEN WHILE THE PATIENT IS REVISED. HE IS INJECTED INTO THE FEMORAL HEAD WITH HYDRACET AND ORDERED TO BE NON-WEIGHT BEARING FOR 6 WEEKS POST-OPERATIVE. DURING THE REVISION SURGERY 2 DISTAL INTERLOCKING SCREWS WERE PLACED. POST-OPERATIVE X-RAYS WERE TAKEN ON AN UNKNOWN DATE AS WELL AS 6 WEEKS POST-OPERATIVE WHEN THE PATIENT IS ALLOWED TO ADVANCE TO WEIGHT BEARING AS TOLERATED AFTER THE VISIT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, WHO HAD BEEN IMPLANTED WITH A TROCHANTERIC NAIL DURING A TROCHANTERIC NAIL FIXATION-ADVANCED PROCEDURE ON (B)(6) 2015, WAS EXPERIENCING PAIN AND PRESENTED AT THE EMERGENCY ROOM (ER) ON SATURDAY, (B)(6) 2015 WHERE X-RAYS WERE TAKEN. THE ER STAFF DID NOT NOTICE THAT THE NAIL WAS BROKEN WHEN READING THE X-RAYS, SO THE PATIENT WAS SENT HOME. THE FOLLOWING MONDAY, ON (B)(6) 2015, THE PATIENT REPORTED TO HIS DOCTOR FOR A FOLLOW UP APPOINTMENT. THE TREATING PHYSICIAN ORDERED ADDITIONAL X-RAYS. THE BROKEN NAIL WAS NO LONGER SUBTLE; IT WAS COMPLETELY AND OBVIOUSLY BROKEN. THE NAIL REPORTEDLY BROKE WHERE THE LAG SCREW ENTERED THE NAIL. THERE WAS NO MENTION OF A FALL IN THE ER DOCUMENTATION. THE PATIENT, WHO ALSO HAD A NON-UNION, WAS REVISED ON (B)(6) 2015. ALL OF THE PREVIOUSLY IMPLANTED HARDWARE (INCLUDING A BROKEN DISTAL SCREW) WAS REMOVED. A NEW, STANDARD TROCHANTERIC NAIL (TFN) WAS IMPLANTED. THIS REPORT IS 1 OF 2 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692217 11MM/130 DEG TI CANN TFNA 400MM/RIGHT - STERILE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES MONUMENT 7960366

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention