BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12MM/125 DEG TI CANN TFNA 380MM/RIGHT - STERILE

    MDR report key: 8289964 · Received January 30, 2019

    Report

    Report Number
    8030965-2019-60497
    Event Type
    Injury
    Date Received
    January 30, 2019
    Report Date
    January 15, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819651104
    PMA / PMN Number
    K160167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART: 04.037.228S, LOT: H542662. MANUFACTURING LOCATION: MONUMENT, MANUFACTURING DATE: JAN 17, 2018, EXPIRY DATE: JAN 01, 2028. THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PRODUCT INVESTIGATION WAS COMPLETED. VISUAL INSPECTION OF THE RETURNED NAIL CONFIRMED THE CONDITION OF POST OPERATIVE BREAKAGE, WHICH AGREES WITH THE REPORTED COMPLAINT CONDITION. THE NAIL WAS RETURNED IN TWO PIECES, WITH THE ROUGH & OBLIQUE BREAK OCCURRING AT THE PROXIMAL HOLE. THE RECEIVED CONDITION AGREE WITH THE COMPLAINT DESCRIPTION CONFIRMING THE COMPLAINT. RELEVANT DESIGN DRAWINGS WERE REVIEWED DURING THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED DURING THIS INVESTIGATION. DIMENSIONAL INSPECTION MET SPECIFICATIONS. A DEFINITIVE ASSIGNABLE ROOT CAUSE FOR THE NAIL BREAKING POST OPERATIVE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. THIS COMPLAINT IS CONFIRMED HOWEVER NO PRODUCT DESIGN ISSUES OR MANUFACTURING DISCREPANCIES THAT WOULD CONTRIBUTE TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED DURING THIS INVESTIGATION. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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 · 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. 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

    CONCOMITANT DEVICES REPORTED: TFNA SCREW (PART# 04.038.195S, LOT # H678733, QUANTITY 1), STARDRIVE LOCKING SCREW (PART # 04.005.534, LOT # L914178, QUANTITY 1), STARDRIVE LOCKING SCREW (PART # 04.005.538, LOT # L676438, QUANTITY 1).

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE DEVICE WAS RECEIVED, AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. ADDITIONALLY, DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED. 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) 2018, PATIENT UNDERWENT A PROCEDURE FOR A HIGH SUB TROCHANTER FRACTURE USING A LONG TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) SYSTEM. TWO MONTHS AFTER THE INITIAL SURGERY, THE TFNA NAIL WAS NOTED BROKEN. ON (B)(6) 2019, PATIENT UNDERWENT REVISION SURGERY DUE TO A BROKEN TFNA NAIL. THE BROKEN TFNA NAIL WAS REMOVED AND REVISED WITH A NEW TFNA WITH AUGMENTATION. PATIENT STATUS AND SURGICAL OUTCOME WERE UNKNOWN. CONCOMITANT DEVICE/S: UNKNOWN HELICAL BLADE (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1); TFNA SCREW (PART 04.038.195S, LOT # H678733, QUANTITY 1); STARDRIVE LOCKING SCREW (PART 04.005.534, LOT L914178, QUANTITY 1); STARDRIVE LOCKING SCREW (PART 04.005.538, LOT L676438, QUANTITY 1). THIS REPORT IS FOR ONE (1) TFNA NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81111 12MM/125 DEG TI CANN TFNA 380MM/RIGHT - STERILE ROD,FIXATION,INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH H542662 07611819651104

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Required Intervention