BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA HELICAL BLADE 110MM STERILE

    MDR report key: 5670206 · Received May 20, 2016

    Report

    Report Number
    3003506883-2016-10085
    Event Type
    Injury
    Date Received
    May 20, 2016
    Report Date
    April 29, 2016
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    PK131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. : PATIENT DOB, AGE & WEIGHT NOT AVAILABLE FOR REPORTING. DATE OF EVENT: UNKNOWN. ORIGINAL IMPLANT DATE WAS APPROXIMATELY 5 WEEKS AGO (EXACT DATE IS UNKNOWN). DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: PART MFG DATE: 04 AUGUST 2015 PART EXP. DATE: 2025-06-30 PART #04.038.310S, LOT #9851278. 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 110MM STERILE PRODUCT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO 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. 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 THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT WAS IMPLANTED WITH TROCHANTERIC FIXATION NAIL SYSTEM ADVANCED (TFNA) PROXIMAL FEMORAL NAILING SYSTEM WITH HELICAL BLADE WAS APPROXIMATELY 5 WEEKS AGO (DATE IS UNKNOWN) AT ANOTHER FACILITY BY A DIFFERENT SURGEON. ON AN UNKNOWN DATE IT WAS DETERMINED THE HELICAL BLADE CUT OUT OF THE FEMORAL HEAD. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2016 WHERE SURGEON REMOVED THE NAIL, HELICAL BLADE, AND ONE UNKNOWN SCREW REPORTED TO BE BETWEEN 36MM TO 40MM FLAT STARDRIVE SCREW. THE PATIENT WAS REVISED TO A TOTAL HIP CONSTRUCT. THERE WAS NO DELAY IN SURGICAL PROCEDURE AND NO HARM TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS COMPLAINT INVOLVES ONE DEVICE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (UNKNOWN PART AND LOT NUMBER), 12MM/130 DEGREE TI CANNULATED TFNA 170MM-STERILE (PART #04.037.242S, LOT #H036231, QUANTITY #1). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324600 TFNA HELICAL BLADE 110MM STERILE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES ELMIRA 9851278

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention