BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA HELICAL BLADE 95MM STERILE

    MDR report key: 5983986 · Received September 28, 2016

    Report

    Report Number
    3003506883-2016-10163
    Event Type
    Injury
    Date Received
    September 28, 2016
    Report Date
    September 12, 2016
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. STERILITY DHR; PART #: 4.038.295S, LOT#: 9885305 (STERILE) - TFNA HELICAL BLADE 95MM - STERILE. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING. 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. UNKNOWN WHEN INFECTION STARTED . (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. MANUFACTURING REVIEW WAS CONDUCTED; 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 95MM STERILE PRODUCT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH ONE NONCONFORMANCE. (B)(4) WAS WRITTEN FOR SCRAPPING 6 PARTS AT DIMENSIONAL INSPECTION FOR COSMETIC TOOL MARKS. IT WAS ALSO NOTED THAT 1 PART WAS REWORKED FOR A POUCH AT THE PREP/SEAL OPERATION, PRIOR TO STERILIZATION. 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. PART #: 04.037.133S, LOT#: 9866570 (STERILE) - 11MM/125 DEG TI CANN TFNA 420 MM/LEFT - STERILE. QUANTITY 5. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. (B)(4), ¿STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING.¿

    Additional Manufacturer Narrative · 1

    PATIENT HEIGHT REPORTED AS (B)(6). PATIENT ID: (B)(6). REPORTED ON INITIAL MEDWATCH AS SEPTEMBER 13, 2016; SHOULD HAVE BEEN SEPTEMBER 12, 2016. 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 THAT ON (B)(6) 2016, THE PATIENT UNDERWENT A HARDWARE REMOVAL OF A TFN-ADVANCED (TFNA) 10MM TITANIUM CANNULATED NAIL AND A 95MM TFNA HELICAL BLADE THE LEFT FEMUR DUE TO AN INFECTION. ALL HARDWARE WAS REMOVED EASILY. THERE WAS NO SURGICAL DELAY OR PATIENT HARM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO NEW HARDWARE WAS IMPLANTED. POST-OPERATIVELY, THE PATIENT HAS BEEN PLACED IN SKELETAL TRACTION UNTIL THE INFECTION HAS CLEARED. THE PATIENT WAS INITIALLY IMPLANTED WITH THE DEVICES ON (B)(6) 2016 DUE TO A LEFT FEMUR FRACTURE. ON AN UNKNOWN DATE, A ROUTINE POST-OPERATIVE EVALUATION REVEALED THE INFECTION. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636331 TFNA HELICAL BLADE 95MM STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES ELMIRA 9885305

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention