BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA HELICAL BLADE 75MM STERILE

    MDR report key: 7045181 · Received November 20, 2017

    Report

    Report Number
    3003506883-2017-10273
    Event Type
    Injury
    Date Received
    November 20, 2017
    Report Date
    October 25, 2017
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER, DATE OF BIRTH, AND WEIGHT NOT AVAILABLE FOR REPORTING. (B)(4). DEVICE WAS NOT EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DHR REVIEW FOR PART # 04.038.275S LOT # 9962653, RELEASE TO WAREHOUSE DATE: 04 FEBRUARY 2016, EXPIRATION DATE: 01 JANUARY 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 75 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. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. X-RAY REVIEW: ON THE PROVIDED X-RAYS IT IS VISIBLE THAT THE BLADE CUT OUT LIKE REPORTED. COMPLAINT IS THEREFORE CONFIRMED. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE REPORTED DEVICES WERE USED IN THE SURGERY FOR THE FEMORAL TROCHANTER FRACTURE ON (B)(6) 2017. IT WAS FOUND ON (B)(6) 2017 THAT THERE WAS A CUT-OUT. THE REDUCTION AND FIXATION FOR THE INTRAMEDULLARY NAIL WERE PERFORMED BY USING THE K-WIRE ANTERIORLY. THE SET SCREWS WERE FINALLY TIGHTENED BY USING THE T-SHAPE TORQUE WRENCH WITH A 1/4 ROTATION BACK, HAVING ITS SLIDING MECHANISM ALLOWED. ALTHOUGH THE REDUCTION WAS NOT SUFFICIENT, THE BLADE ITSELF DID NOT HAVE THE SLIDING MECHANISM AT ALL; THEREFORE, THE HEAD OF THE FEMUR BECAME SHORTENED. THE MEDICAL FOLLOW-UP HAD BEEN DONE SO FAR. IF THE PATIENTS SOME PAIN DUE TO THE PROGRESSION OF THE BLADE CUT-OUT, THE RE-OPERATION (THE BLADE REPLACEMENT OR THE BHA) WILL BE CONSIDERED. PATIENT HAD NO PAIN. THE PATIENT IS CURRENTLY IN THE NURSING HOME AND BARELY WALKS. THE INITIAL SURGERY WAS EXTENDED FOR 15 MINUTES. CONCOMITANT DEVICES REPORTED: END CAP FOR TFNA 0 MM (04.038.000S, LOT L243179, QUANTITY 1), 10 MM 125 DEGREE CANNULATED TFNA 200 MM (04.037.013S, LOT 9859874, QUANTITY 1), 5.0 MM LOCKING SCREW WITH T25 STARDRIVER 36 MM FOR IM NAIL (04.005.526S, LOT L019547, QUANTITY 1). THIS REPORT IS FOR ONE (1) TFNA HELICAL BLADE 80 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824268 TFNA HELICAL BLADE 75MM STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES ELMIRA 9962653

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention END CAP (04.038.000S, LOT L243179, QTY 1)| LOCKING SCREW (04.005.526S, LOT L019547, QTY 1)| TFNA NAIL (04.037.013S, LOT 9859874, QTY 1)