BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURELOCK CONNECTOR LE F/LONG PROX-FEMNAI

    MDR report key: 14842545 · Received June 28, 2022

    Report

    Report Number
    8030965-2022-04417
    Event Type
    Malfunction
    Date Received
    June 28, 2022
    Report Date
    June 28, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZH
    UDI-DI
    07611819880887
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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.

    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. H10 ADDITIONAL NARRATIVE: 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 SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: THIS PC IS RELATED TO (B)(4) WHICH REPORTS ABOUT THE DEFECTS ON THE REPLACEMENTS. THIS PC REPORTS ABOUT THE DEVICES WHICH NEEDED TO BE REPLACED DUE TO SOME DEFECTS. IT WAS REPORTED THAT THE PRINTINGS ON THE SURFACE OF SOME DEVICES BECAME FAINT OR SHAVED DUE TO AGING, AND THE SURELOCK CONNECTOR WAS BROKEN. THE HOSPITAL REQUESTED REPLACEMENTS FOR THOSE DEVICES. SINCE THE DEVICES WITH FAINTED PRINTING AND SHAVED SURFACES AND BROKEN SURELOCK CONNECTOR ARE COMPONENTS OF AN INSTRUMENT SET FOR A PFNA SURGERY AND THE SPECIFIC PRODUCT CODES ARE UNKNOWN, WE REGISTER 03.010.065, 03.010.200 AND 03.010.201 TEMPORALLY AS IMPACTED PRODUCTS. THE INSTRUMENT SET INCLUDING THE IMPACTED PRODUCTS HAVE BEEN OUTSOURCED TO THE HOSPITAL FOR SEVERAL YEARS. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) SURELOCK CONNECTOR LE F/LONG PROX-FEMNAI. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1813729 SURELOCK CONNECTOR LE F/LONG PROX-FEMNAI GUIDE, SURGICAL, INSTRUMENT FZH SYNTHES GMBH 07611819880887

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DRILLSL 8/4.2 F/03.010.063| SURELOCK AIMINGARM F/AFN