BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDEWIRE Ø2.5 W/DRILL TIP L200 SST

    MDR report key: 14401672 · Received May 13, 2022

    Report

    Report Number
    8030965-2022-03208
    Event Type
    Malfunction
    Date Received
    May 13, 2022
    Date of Event
    April 19, 2021
    Report Date
    May 13, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZH
    UDI-DI
    07611819755116
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. 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.

    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: B5 H6: THE PHOTO WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL ANALYSIS OF THE PHOTO REVEALED THAT THE GUIDEWIRE Ø2.5 W/DRILL TIP L200 SST HAS BROKEN IN MIDDLE OF SURGERY. NO OTHER PROBLEMS WAS RETURNED. ¿ AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED FOR GUIDEWIRE Ø2.5 W/DRILL TIP L200 SST. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART # 310.243 LOT # 423P726 MANUFACTURING SITE: WERK SELZACH RELEASE TO WAREHOUSE DATE: 12 OCT2021 SUPPLIER: SYNTHES USA HQ, INC A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY, THE DRILL BIT IS PART AT THE TIME OF DRILLING. THIS REPORT IS FOR ONE (1) GUIDEWIRE Ø2.5 W/DRILL TIP L200 SST. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THAT THE DRILL BIT BROKE AT THE TIME OF THE DRILLING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE PATIENT OUTCOME IS REPORTED AS SATISFYING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039138 GUIDEWIRE Ø2.5 W/DRILL TIP L200 SST GUIDE, SURGICAL, INSTRUMENT FZH SYNTHES GMBH 423P726 07611819755116

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown