BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA HELICAL BLADE 95MM STERILE

    MDR report key: 6845230 · Received September 6, 2017

    Report

    Report Number
    3003506883-2017-10197
    Event Type
    Injury
    Date Received
    September 6, 2017
    Report Date
    August 15, 2017
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: TROCHANTERIC FIXATION NAIL ADVANCED 11 MM/175 MM NAIL (ITEM # 04.037.112S, LOT # H232521, QUANTITY 1 EACH) 5.0 MM DISTAL LOCKING SCREW (ITEM # 04.005.524S, LOT # H333989, QUANTITY 1 EACH). (B)(4) USED FOR: THE REVISION SURGERY THAT TOOK PLACE ON (B)(6) 2017. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: DHR REVIEW FOR PART # 04.038.295S LOT # H269310, RELEASE TO WAREHOUSE DATE: 02 FEBRUARY 2017, EXPIRATION DATE: 31 DECEMBER 2026, MANUFACTURING SITE: (B)(4). DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF TFNA HELICAL BLADE 95 MM STERILE PRODUCT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK NOR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO NON-CONFORMANCE NOTED. THIS RAW MATERIAL 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. 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 REPORT THAT THE PATIENT HAD ORIGINAL SURGERY ON (B)(6) 2017 FOR TREATMENT OF A HIP FRACTURE DUE TO THE FALL. PATIENT WAS IMPLANTED WITH ONE (1) (TFNA) TROCHANTERIC FIXATION NAIL ADVANCED 11 MM/175 MM NAIL, ONE (1) TFNA 95 MM HELICAL BLADE AND ONE (1) 5.0 MM DISTAL LOCKING SCREW. POST-OPERATIVE, ON (B)(6) 2017 DURING A DOCTOR¿S OFFICE VISIT, PATIENT MADE KNOWN TO THE SURGEON THAT SHE WAS EXPERIENCING HIP PAIN. X-RAYS WERE TAKE WHICH REVEALED THAT THE 95 MM HELICAL BLADE HAD CUT OUT THRU THE PATIENTS FEMUR HEAD BONE. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2017. SURGEON REMOVED THE TFNA 95 MM HELICAL BLADE IMPLANT AND RE-IMPLANTED A SMALL SIZE 80 MM HELICAL BLADE IMPLANT. BOTH THE ORIGINAL NAIL AND DISTAL LOCKING SCREW WERE LEFT IN THE PATIENTS FEMUR BONE. SURGEON OBSERVED THAT THE EXPLANTED 95 MM HELICAL BLADE IMPLANT WAS IN GOOD CONDITION. NO FRAGMENTS WERE GENERATED DURING THIS PROCEDURE. HOSPITAL HAS RETAINED THE IMPLANT. REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO TIME DELAY. PATIENT IS REPORTED IN STABLE CONDITION. SALES CONSULTANT HAS NO MORE INFORMATION TO REPORT ON THIS EVENT. THIS REPORT IS FOR ONE (1) DEVICE CONCOMITANT DEVICES: TROCHANTERIC FIXATION NAIL ADVANCED 11 MM/175 MM NAIL (ITEM # 04.037.112S, LOT # H232521, QUANTITY 1 EACH). THE 5.0 MM DISTAL LOCKING SCREW (ITEM # 04.005.524S, LOT # H333989, QUANTITY 1 EACH). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626308 TFNA HELICAL BLADE 95MM STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES ELMIRA H269310

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention