BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA HELICAL BLADE 100MM STERILE

    MDR report key: 6159854 · Received December 9, 2016

    Report

    Report Number
    3003506883-2016-10198
    Event Type
    Injury
    Date Received
    December 9, 2016
    Report Date
    November 17, 2016
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: (B)(4); PART# 04.038.300S / 9806830; MFG DATE: 16 JULY 2015; PART EXP. DATE: 01 JULY 2025. 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 100MM STERILE PRODUCT 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. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: (B)(6). 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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

    DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE REPORTED DEVICES WERE USED IN THE INITIAL SURGERY FOR FEMUR TROCHANTERIC FRACTURE ON (B)(6) 2016. IN THE SURGERY THE SURGEON USED TFN-ADVANCED MIDDLE NAIL. WHEN THE PATIENT CAME TO SEE THE SURGEON FOR PAIN, HE TOOK X-RAYS AND FOUND THE CUT-OUT BLADE. ON (B)(6) 2016, THE SURGEON EXPLANTED THE ABOVE-MENTIONED TFN-ADVANCED MIDDLE NAIL. FINALLY HE COMPLETED THA (TOTAL HIP ANTROPLASTY). THIS COMPLAINT INVOLVES 1 PART. CONCOMITANT MEDICAL PRODUCTS: 1X 04.037.045S / 7984383 (TFNA FEM NAIL Ø10 LE 130° L235 TIMO15). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    CONCOMITANT DEVICES REPORTED: LOCKSCR Ø5 L34 F/NAILS TAN LIGHT GREEN (PART # 04.005.524S, LOT # 9558612, QUANTITY 1). TFNA END CAP EXTENS. 0 TAN (PART # 04.038.000S, LOT # 8986663, QUANTITY 1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811279 TFNA HELICAL BLADE 100MM STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES ELMIRA 9806830

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention