BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 22MM

    MDR report key: 15285886 · Received August 24, 2022

    Report

    Report Number
    8030965-2022-05983
    Event Type
    Malfunction
    Date Received
    August 24, 2022
    Date of Event
    July 27, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    UDI-DI
    10886982119032
    PMA / PMN Number
    K100776
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. COMMON DEVICE NAME: ADDITIONAL PROCODE: HRS. DEVICE AVAILABLE FOR EVALUATION:COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INITIAL REPORTER IS A SYNTHES EMPLOYEE. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. PART # 04.211.022S. LOT # 8L93383. MANUFACTURING SITE: WERK SELZACH. RELEASE TO WAREHOUSE DATE: (B)(6) 2022. EXPIRATION DATE: 01 JAN2032. SUPPLIER: FRÜH VERPACKUNGSTECHNIK AG. NON-STERILE PART # 04.211.022. NON-STERILE LOT # 546P500. MANUFACTURING SITE: WERK SELZACH. RELEASE TO WAREHOUSE DATE: (B)(6) 2021. SUPPLIER: SYNTHES USA HQ, INC. 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

    DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 DURING AN OSTEOSYNTHESIS FOR RIGHT DISTAL HUMERUS FRACTURE, FOUR (4) CONSECUTIVE LOCKING SCREWS FAILED TO LOCK INTO THE FOUR HOLES OF A PLATE. THE SURGEON HAD BEEN FOLLOWING THE SURGICAL TECHNIQUE AND HAD STARTED INSERTING THE LOCKING SCREWS USING A DRILL SLEEVE. THE SURGEON CONSULTED WITH THE SALES REP AND ULTIMATELY DECIDED TO PROCEED USING A NEW PLATE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH LESS THAN 30 MINUTES OF DELAY. THIS REPORT IS FOR A 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 22MM. THIS IS REPORT 4 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2256423 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 22MM SCREW, FIXATION, BONE HWC SYNTHES GMBH 04.211.022 8L93383 10886982119032

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L20 TA| VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L22 TA| VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L22 TA| VA-LCP DHP 2.7/3.5 DORSO-LAT W/SUPP-LAT