BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5MM HEX DRIVER SHAFT SELF-RETAINING L 100MM QC

    MDR report key: 17237569 · Received June 30, 2023

    Report

    Report Number
    8030965-2023-08207
    Event Type
    Malfunction
    Date Received
    June 30, 2023
    Date of Event
    January 1, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    UDI-DI
    07612334122179
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. H10 ADDITIONAL NARRATIVE: B3: DATE OF EVENT IS AN UNKNOWN DATE IN 2023. E3: REPORTER IS A SYNTHES EMPLOYEE. H3, H6: PART: 03.133.175 SYNTHESE LOT: H884516 SUPPLIER LOT: H884516 RELEASE TO WAREHOUSE DATE: 02 JANUARY 2020 SUPPLIER: PARAGON MEDICAL NO NONCONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE TIP OF THE DEVICE WAS HEAVILY STRIPPED. THE OBSERVED CONDITION WAS CONSISTENT AS AN END OF LIFE INDICATOR FOR THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED. THE DEFORMED ALLEGATION CANNOT BE CONFIRMED. AFTER A VISUAL INSPECTION PER GUIDANCE, IT WAS DETERMINED THAT THE REUSABLE INSTRUMENT DEVICE WAS STRIPPED FROM REPEATED USE AND SERVICING; THEREFORE, FURTHER INVESTIGATION FOR THE REPORTED COMPLAINT DEVICE IS NOT REQUIRED. AS PART OF DEPUY SYNTHESE QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS UNCONFIRMED AS THE OBSERVED STRIPPED OF SCRDRIVERSHAFT-HEX SELF-RETAIN 2.5 L100 [03.133.175/H884516]. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. IT WAS DETERMINED THAT THE REUSABLE INSTRUMENT WAS WORN FROM REPEATED USE AND SERVICING. 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. 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

    IT WAS REPORTED THAT WHILE RESETTING TRAYS ON AN UNKNOWN DATE, TWO DRIVERS WERE WARPED. THERE WAS NO PATIENT INVOLVEMENT. UPON MANUFACTURER INVESTIGATION, IT WAS DETERMINED THAT THE TIP OF THE HEX DRIVER WAS HEAVILY STRIPPED. THIS REPORT IS FOR A 2.5MM HEX DRIVER SHAFT SELF-RETAINING L 100MM QC. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1422998 2.5MM HEX DRIVER SHAFT SELF-RETAINING L 100MM QC SCREWDRIVER HXX SYNTHES GMBH H884516 07612334122179

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 2.5 HEX DRVR SFT SELF-RETAINING L 100 QC