BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAFT FOR 90° SCREWDRIVER

    MDR report key: 13146165 · Received January 3, 2022

    Report

    Report Number
    8030965-2022-00007
    Event Type
    Malfunction
    Date Received
    January 3, 2022
    Date of Event
    December 6, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    UDI-DI
    07611819187474
    PMA / PMN Number
    K082649
    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). ADDITIONAL NARRATIVE: ADDITIONAL PRODUCT CODE: DZJ, DZI. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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. E3: REPORTER IS A SYNTHES EMPLOYEE. H3, H6: PART: 03.505.003, LOT: 8213959, MANUFACTURING SITE: SELZACH, SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: JUNE 01, 2017. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE PRODUCT WAS RETURNED TO US CUSTOMER QUALITY (CQ) FOR EVALUATION. THE US CQ TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SHAFT FOR 90 SCREWDRIVER HAD NO SURFACE DAMAGE/DEFECTS THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE DEVICE WAS RETURNED WITH ALL THE COMPONENTS STILL IN ASSEMBLED CONDITION. THE COMPONENTS COULD NOT BE DISASSEMBLED. THE DIMENSIONAL INSPECTION COULD NOT BE PERFORMED AS THE COMPONENTS COULD NOT BE DISASSEMBLED. A FUNCTIONAL TEST TO ASSES THE CONDITION OF THE INNER SHAFT WAS CONDUCTED. THE INNER SHAFT COULD NOT BE REMOVED FROM THE SCREW DRIVER SHAFT. THUS DEVICE FAILED TO FUNCTIONED AS INTENDED. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE COMPLAINT CONDITION WAS CONFIRMED FOR THE SHAFT FOR 90 SCREWDRIVER AS THE DEVICE COMPONENTS COULD NOT DISASSEMBLED. THE ROOT CAUSE FOR THE REPORTED COMPLAINT CONDITION IS ATTRIBUTED TO A DESIGN- RELATED/MANUFACTURING ISSUE. RELEVANT ACTIONS HAVE BEEN TAKEN TO ADDRESS THE ISSUE. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DRAWING/SPECIFICATIONS REVIEWED THE FOLLOWING DRAWINGS REFLECTING THE CURRENT AND MANUFACTURED REVISIONS WERE REVIEWED: SHAFT COMPLETE, 90° SCREWDRIVER , SHAFT AND HEAD COMPLETE , SHAFT F/SCREWDRIVER 90° , COVER SCREWDRIVER 90°. 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: UPDATED DATA: D4, H4. H3, H6: THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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. CORRECTED DATA: D9, H3, H6.

    Description of Event or Problem · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED FROM THE (B)(4) DISTRIBUTION CENTER ON (B)(6) 2021, THAT THE SHAFTS WERE NOT ABLE TO BE DETACHED. NO FURTHER INFORMATION IS AVAILABLE. THE SAME EVENT REPORTED IN (B)(4) OCCURRED THIS TIME. THIS REPORT IS FOR (1) SHAFT FOR 90° SCREWDRIVER. THIS REPORT IS 5 OF 11 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791745 SHAFT FOR 90° SCREWDRIVER SCREWDRIVERS HXX SYNTHES GMBH 8213959 07611819187474

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SHAFT| SHAFT| SHAFT| SHAFT| SHAFT| SHAFT| SHAFT| SHAFT| SHAFT