BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASEPLATE INSERTER ROD

    MDR report key: 20063983 · Received August 26, 2024

    Report

    Report Number
    1818910-2024-17972
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Date of Event
    August 4, 2024
    Report Date
    August 26, 2024
    Manufacturer
    DEPUY IRELAND - 3015516266
    Product Code
    LXH
    UDI-DI
    10603295547235
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: IT WAS REPORTED THAT BASEPLATE INSERTER TIP THREADS WERE STRIPPED DURING THE CASE. SURGICAL DELAY UNKNOWN. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THE BASEPLATE INSERTER ROD EXHIBITED CROSS THREADED TIP THREADS. ADDITIONALLY, A FOREIGN SUBSTANCE WAS OBSERVED IN THE SAME AREA. THE THREADS CONDITION CAN BE ATTRIBUTED TO UNINTENDED USE ERROR, WITH THE DAMAGE LIKELY RESULTING FROM OVERTIGHTENING, OFF-AXIS ASSEMBLY OR PRYING MOTION WHILE DEVICE IS ASSEMBLED. FOREIGN SUBSTANCE CONDITION MAY OCCUR DURING THE CLEANING/STERILIZATION PROCESS, AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU) 0902-60-082 REV C. THE IFU SPECIFICALLY ADVISES: "USE A SOFT NON-METALLIC BRISTLE BRUSH (PLASTIC BRISTLES, LIKE NYLON) OR SPONGE TO THOROUGHLY CLEAN ALL TRACES OF BLOOD AND DEBRIS FROM ALL DEVICE SURFACES FOR A MINIMUM OF ONE MINUTE" ADDITIONALLY, "PAY SPECIAL ATTENTION TO ANY DEVICE THREADS, RATCHETS, HINGES, OR AREAS WHERE FLUID CAN ACCUMULATE." FAILURE TO ADEQUATELY CLEAN THESE AREAS CAN LEAD TO THE ACCUMULATION OF FOREIGN SUBSTANCES, WHICH MAY DRY OR HARDEN OVER TIME, ULTIMATELY AFFECTING THE DEVICE'S FUNCTIONALITY. PROPER ADHERENCE TO THESE GUIDELINES HELPS PREVENT SUCH COMPLICATIONS. A FUNCTIONAL TEST WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. A DIMENSIONAL INSPECTION WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE BASEPLATE INSERTER ROD WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. 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 HISTORY LOT: THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION THAT HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BASEPLATE INSERTER TIP THREADS WERE STRIPPED DURING THE CASE. SURGICAL DELAY UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276394 BASEPLATE INSERTER ROD SHOULDER INSTRUMENT - INSERTION DEVICE LXH DEPUY IRELAND - 3015516266 201286 10603295547235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown