BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER HANDLE WITH HEX COUPLING-MEDIUM

    MDR report key: 11362116 · Received February 22, 2021

    Report

    Report Number
    8030965-2021-01229
    Event Type
    Malfunction
    Date Received
    February 22, 2021
    Date of Event
    January 1, 2021
    Report Date
    February 1, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    UDI-DI
    07611819753389
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10: ADDITIONAL NARRATIVE: D9 H3, H4, H6: PART 311.006, LOT T192678: MANUFACTURING SITE: TUTTLINGEN. RELEASE TO WAREHOUSE DATE: JUNE 23, 2020. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3, H6: A PRODUCT INVESTIGATION WAS COMPLETED: VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED NO PHYSICAL DEFECT. DURING FUNCTIONAL ASSESSMENT SEVERAL ATTEMPTS TO REMOVE THE SCREWDRIVER FROM THE HANDLE WERE UNSUCCESSFUL. THE SCREWDRIVER WAS STUCK TO THE HANDLE AND COULD NOT BE REMOVED BY USING THE QUICK RELEASED MECHANISM OF THE HANDLE AND EXERTING PULLING FORCES; THUS THE COMPLAINT IS CONFIRMED. NO DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO THE SCREWDRIVER BEING STUCK IN THE HANDLE PREVENTING THEN THE INSPECTION OF THE HANDLE RELEVANT DIMENSIONS. THE CURRENT AND MANUFACTURED TO DRAWINGS WERE REVIEWED; NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. THIS COMPLAINT IS CONFIRMED AS THE HANDLE WAS RETURNED WITH THE SCREWDRIVER THAT COULD NOT BE DISASSEMBLED. THE MATING DEVICE APPEARED TO BE STUCK. ALTHOUGH NO ROOT CAUSE COULD DEFINITIVELY BE DETERMINED FOR THE REPORTED COMPLAINT CONDITION, IT IS LIKELY THAT A COMPONENT FAILURE OCCURRED. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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. 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

    PRODUCT COMPLAINT # (B)(4). EVENT YEAR IS REPORTED AS 2021, HOWEVER EXACT DATE OF EVENT IS UNKNOWN. 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 AS NO PRODUCT WAS 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NEW (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THE HOSPITAL NOTIFIED THAT AFTER EACH NEURO CLOSURE CASE, THE DRIVER ARE HAVING TO BE SENT DOWN TO ENGINEERING TO REMOVE THE HANDLE FROM THE SHAFT. THE PATIENT DOES NOT REQUIRE ANY REVISION SURGERY OR HARDWARE REMOVAL. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) SCREWDRIVER HANDLE WITH HEX COUPLING-MEDIUM. THIS IS REPORT 1 OF 2 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256749 SCREWDRIVER HANDLE WITH HEX COUPLING-MEDIUM SCREWDRIVERS HXX SYNTHES GMBH T192678 07611819753389

    Patients

    Seq Age Sex Outcome Treatment
    1 D-02LE-MEDIUM W/HEX-COUPL| MATRIXNEURO SCRDRIVERSHAFT 1.5 MED SELF-| MATRIXNEURO SCRDRIVERSHAFT 1.5 MED SELF-