BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER HANDLE WITH HEX COUPLING-MEDIUM

    MDR report key: 11366542 · Received February 23, 2021

    Report

    Report Number
    8030965-2021-01267
    Event Type
    Malfunction
    Date Received
    February 23, 2021
    Date of Event
    January 1, 2021
    Report Date
    February 2, 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. 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. THE DEVICE WAS DISASSEMBLED FROM THE SCREWDRIVER USING THE RELEASE MECHANISM. THE SCREWDRIVER WAS RE-ASSEMBLED BACK WITH THE DEVICE WITHOUT ANY ISSUE. THE SCREWDRIVER DID NOT SEEM STUCK OR JAMMED OR NEITHER A TOOL WAS USED TO ASSEMBLE OR DISASSEMBLE THE DEVICES. THE COMPLAINT WAS NOT REPLICATED AS THE DEVICE WAS ABLE TO BE DISASSEMBLED AND ASSEMBLE BACK AS INTENDED. NO DIMENSIONAL INSPECTION WAS PERFORMED AS THERE WAS NO DAMAGE THAT WARRANTED DIMENSIONAL INSPECTION. THE CURRENT AND MANUFACTURED TO DRAWINGS WERE REVIEWED; NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. THIS COMPLAINT IS NOT CONFIRMED AS NO DEFECT WAS FOUND ON THE RETURNED DEVICE AND THE DEVICE WAS ABLE TO BE DISASSEMBLED AND RE-ASSEMBLED BACK WITH THE MATING DEVICE WITHOUT ANY ISSUE. NO ROOT CAUSE COULD DEFINITIVELY BE DETERMINED FOR THE REPORTED COMPLAINT CONDITION. 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

    EVENT OCCURRED ON AN UNKNOWN DATE IN 2021. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2021, TWO SCREWDRIVER HANDLES WITH HEX COUPLING NEEDED TO BE REMOVED FROM TWO MATRIXNEURO SCREWDRIVER SHAFTS AFTER PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE SCREWDRIVER HANDLE WITH HEX COUPLING-MEDIUM. THIS IS REPORT 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265975 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-