BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECT SLEEVE 11/8 GREEN

    MDR report key: 9265568 · Received November 1, 2019

    Report

    Report Number
    8030965-2019-69193
    Event Type
    Malfunction
    Date Received
    November 1, 2019
    Report Date
    September 12, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    LXH
    UDI-DI
    07611819291362
    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. 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: 356.831, LOT: 9854210, MANUFACTURING SITE: BETTLACH, RELEASE TO WAREHOUSE DATE: APRIL 28, 2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE 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.

    Additional Manufacturer Narrative · 1

    REPORT WAS INITIALLY SUBMITTED ON OCTOBER 09, 2019 BUT THE FDA SITE WAS DOWN. ADVISED BY FDA ON NOVEMBER 01, 2019 TO RESUBMIT MEDWATCH. 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. 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 ON AN UNKNOWN DATE THAT AN ISSUE OCCURRED DURING THE DISTAL LOCKING IN A PFNA SHORT 170 MM / 125°/D 10 MM. THE IMPLANTS ( NAIL AND SCREWS ) ARE IMPLANTED IN THE PATIENT. PATIENT CONDITION IS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN PFNA SHORT NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS IS REPORT 4 FOR 8 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1060077 PROTECT SLEEVE 11/8 GREEN MISC ORTHO SURGICAL INSTR LXH OBERDORF SYNTHES PRODUKTIONS GMBH 9854210 07611819291362

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK - NAILS: PFNA| UNK - SCREWS: LOCKING| UNK - NAILS: PFNA| UNK - SCREWS: LOCKING