BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.9MM TI LOCKING BOLT 40MM

    MDR report key: 8395327 · Received March 6, 2019

    Report

    Report Number
    8030965-2019-61777
    Event Type
    Malfunction
    Date Received
    March 6, 2019
    Date of Event
    November 8, 2018
    Report Date
    March 4, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HTY
    PMA / PMN Number
    K970733
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. ADDITIONAL DEVICE PRODUCT CODES: JDW, JDS, JDN, HSB. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 459.400 . LOT: 5941577 . MANUFACTURING SITE: SALZBURG. RELEASE TO WAREHOUSE DATE: 12.JAN.2017. 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

    THIS REPORT CAPTURES THE INTRA-OP EVENTS, WHEREIN AN UNKNOWN SCREW BROKE OFF DURING REMOVAL, WHILE RELATED COMPLAINT (B)(4) WILL CAPTURE THE POST-OP EVENTS, WHEREIN A REMOVAL PROCEDURE WAS PERFORMED DUE TO PSEUDOARTHROSIS. CONCOMITANT DEVICES REPORTED: FEMORAL NECK SCREW FOR TFN (PART # 04.032.110S, LOT # H318684, QUANTITY 1), TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL (PART # 456.314, LOT # H330070, QUANTITY 1). THIS REPORT IS FOR ONE (1) 4.9MM TI LOCKING BOLT 40MM.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN SCREW/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. 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 DURING A REMOVAL PROCEDURE ON (B)(6) 2018, AN UNKNOWN SCREW WAS BROKE. INITIALLY THE PATIENT HAD DEVICE IMPLANTATION ON (B)(6) 2017 DUE TO A TROCHANTERIC BREAKAGE. THERE WAS A SURGICAL DELAY OF UNKNOWN MINUTES REPORTED. PATIENT STATUS AND SURGICAL OUTCOME WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN BLADE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL (PART # 456.314, LOT # H330070, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189072 4.9MM TI LOCKING BOLT 40MM PIN,FIXATION,SMOOTH HTY OBERDORF SYNTHES PRODUKTIONS GMBH 5941577

    Patients

    Seq Age Sex Outcome Treatment
    1 10MM/125 DEG TI CANN TROCH FIXATION NAIL 170MM| FEM-NECKSCR F/TFN Ø11 L110 TAN GOLD| SEE EVENT DESCRIPTION