BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA-II BLADE L95 TAN

    MDR report key: 8550169 · Received April 25, 2019

    Report

    Report Number
    8030965-2019-63137
    Event Type
    Injury
    Date Received
    April 25, 2019
    Report Date
    March 29, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819394230
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. COMPLAINED ISSUE COULD NOT BE REPLICATED AND/OR CONFIRMED (BLADE CUT OUT) BASED ON THE AVAILABLE INFORMATION (INCL. PICTURES AND/OR X-RAY¿S). DEVICE HISTORY LOT. PART: 04.027.054S. LOT: 1L52462. MANUFACTURING SITE: BETTLACH. RELEASE TO WAREHOUSE DATE: 24.SEP.2018. EXPIRY DATE: 01.SEP.2028. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 · 0

    IT WAS REPORTED THAT ON MARCH 29, 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) II BLADE CUT OUT. INITIALLY, THE PATIENT HAD A PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) II IMPLANTATION ON (B)(6) 2018. THE IMPLANT WAS SUCCESSFULLY EXPLANTED BY USING GENERAL ORTHOPEDIC INSTRUMENTS AVAILABLE WITH THE SURGEON. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 45 MINUTES SURGICAL DELAY. PATIENT OUTCOME IS STABLE AND MAY UNDERGO A TOTAL HIP REPLACEMENT (THR) IN THE FUTURE. CONCOMITANT DEVICES REPORTED: PFNA NAIL (PART# 472.116S, LOT# L144519, QUANTITY 1) AND PFNA LOCKING SCREW (PART# 459.340, LOT# 5943218, QUANTITY 1).

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. (B)(4). A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) II BLADE CUT OUT. INITIALLY, THE PATIENT HAD A PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) II IMPLANTATION ON (B)(6) 2018. PATIENT AND PROCEDURE OUTCOME WAS UNKNOWN. CONCOMITANT DEVICES REPORTED: PFNA NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1) AND PFNA LOCKING SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346187 PFNA-II BLADE L95 TAN ROD, FIXATION, INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH 1L52462 07611819394230

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention BOLT Ø4.9 SELF-TAP L34 TAN GREEN| PFNA-II Ø11 SM 130° L200 TAN