BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0/2.4MM CRUCIFORM SCRWDRVR BLD/SL-RETAINNG W/HEX COUPLING

    MDR report key: 19982253 · Received August 14, 2024

    Report

    Report Number
    8030965-2024-09933
    Event Type
    Malfunction
    Date Received
    August 14, 2024
    Date of Event
    June 20, 2024
    Report Date
    August 14, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    UDI-DI
    07611819725607
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: E3: REPORTER IS A J&J EMPLOYEE. H3, H4, H6: PART # 313.928. SYNTHES LOT # H884783. SUPPLIER LOT # H884783. RELEASE TO WAREHOUSE DATE: 08 JAN 2020. SUPPLIER: (B)(4). NO NCR'S 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 INSPECTION OF THE RETURNED DEVICES FOUND THAT THE CRUCIFORM TIP WAS DAMAGED AND DEFORMED DUE TO REPEATED USAGE. HOWEVER, WITHOUT MATING COMPONENT AN ASSEMBLING ISSUE WAS NOT ABLE TO CONFIRM. THE OBSERVED CONDITION WAS IDENTIFIED AS AN END OF LIFE INDICATOR; DAMAGE CONSISTENT WITH REPEATED USE AND SERVICING. THE LIFECYCLE REQUIREMENTS OF THE DEVICE ARE EVENT RELATED AND DEPEND ON THE USE AND INSPECTION OF THE DEVICE IN CLINICAL PRACTICE. AS THE DEVICE CAN BE DAMAGED ON THE FIRST OR 100TH USE, THE DEVICE MUST BE PROPERLY INSPECTED PRIOR TO EACH SURGICAL USE. REFER TO THE DEVICE/COUNTRY SPECIFIC IFU FOR INFORMATION RELATED TO END OF LIFE, REPROCESSING INSTRUCTIONS, AND INSPECTION PROCEDURES. A DIMENSIONAL INSPECTION WAS UNABLE TO BE PERFORMED DUE TO THE POST-MANUFACTURING DAMAGE. A FUNCTIONAL TEST WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE SCRDRIVERSHAFT-2/2.4 CRUCIF SELF-HOLDING WOULD HAVE CONTRIBUTED TO THE COMPLAINED ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO END OF LIFE, AND IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS REQUIRED. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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 ON (B)(6) 2024, THREE SCREWDRIVERS IN THE LOANER SET WERE MISSHAPEN AND UNUSABLE. THERE WAS NO DELAY FOR THE PROCEDURE. OTHER SCREWDRIVERS HAVE BEEN USED. NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) 2.0/2.4MM CRUCIFORM SCRWDRVR BLD/SL-RETAINNG W/HEX COUPLING. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220823 2.0/2.4MM CRUCIFORM SCRWDRVR BLD/SL-RETAINNG W/HEX COUPLING SCREWDRIVER HXX SYNTHES GMBH H884783 07611819725607

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown