BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFNA-II BLADE L115 TAN

    MDR report key: 10248072 · Received July 8, 2020

    Report

    Report Number
    8030965-2020-04728
    Event Type
    Malfunction
    Date Received
    July 8, 2020
    Date of Event
    June 23, 2020
    Report Date
    June 23, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819394278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. 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. DEVICE HISTORY LOT: PART NUMBER: 04.027.058S. LOT NUMBER: 8874113. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 04. MARCH 2014. EXPIRY DATE: 01. FEB. 2024. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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. 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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR FEMORAL TROCHANTERIC FRACTURES BY USING THE PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) SYSTEM. DURING THE SURGERY, AFTER INSERTION OF THE BLADE, THE SURGEON TRIED TO LOCK THE BLADE, BUT WAS UNSUCCESSFUL AS THE IMPACTOR GOT STUCK IN THE BLADE DUE TO A WRONG LOCKING DIRECTION OF THE BLADE. AS HE COULD NOT LOCK THE BLADE, HE TRIED TO PULL OUT THE IMPACTOR. THEN, THE HANDLE OF THE IMPACTOR CAME OFF AND BROKE. HE REMOVED THE BLADE WITH A GUIDE WIRE AND SLEEVE, AND THEN INSERTED THE BLADE AGAIN BY USING ANOTHER INSTRUMENT. THERE WAS NO CONSEQUENCE TO THE PATIENT AND THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A LESS-THAN-30-MINUTE DELAY. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNK - GUIDES/SLEEVES/AIMING: GUIDE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN), UNK - GUIDES/SLEEVES/AIMING: SLEEVE, (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) PFNA-II BLADE L115 TAN. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712411 PFNA-II BLADE L115 TAN ROD, FIXATION, INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH 8874113 07611819394278

    Patients

    Seq Age Sex Outcome Treatment
    1