BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSET HV BONE CEMENT 40G

    MDR report key: 22714821 · Received August 5, 2025

    Report

    Report Number
    1818910-2025-13665
    Event Type
    Malfunction
    Date Received
    August 5, 2025
    Date of Event
    July 17, 2025
    Manufacturer
    DEPUY CMW - 9610921
    Product Code
    LOD
    UDI-DI
    10603295168331
    PMA / PMN Number
    K023012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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). INVESTIGATION SUMMARY: EVENT TOOK PLACE IN A NON-CLINICAL SETTING. NO PATIENT HARM, PRODUCT USED DURING DEMONSTRATION. FIRST CUSTOMER INTERACTION WITH PRODUCT. JJ EMPLOYEES PROVIDED DIRECTIONAL TRAINING PRIOR TO MIXING. PRODUCT: SMARTMIX SYRINGE PLUS (REF: 5401-76-511): LOT 33498, DATE OF MANUFACTURE: 2024-09-19, EXP 2026-09-19, PRODUCT: SMARTMIX GUN (REF: 5401-76-513): SN (B)(6), PRODUCT: 3 X SMARTSET HV BONE CEMENT (REF: 3092-040) LOT: 4552778 EXPIRY DATE: 2026-08-31 VACUUM PUMP: ELECTRIC DEMONSTRATION VACUUM PUMPS (USED FOR DEMOS ONLY). UNKNOWN THEATRE TEMPERATURE. MIXING TECHNIQUE OBSERVED: ADDED 3 X MONOMER AMPOULES VIA THE FUNNEL. ADDED 3 X BONE CEMENT POWDER VIA THE FUNNEL STARTED THE TIMER ON FIRST ADDITION OF THE BONE CEMENT POWDER AND FINAL ADDITION WAS COMPLETE AFTER ~ 00:00:15 (15 SECONDS) MIXED THE BONE CEMENT UNTIL ~ 00:00:50 (50 SECONDS) REMOVED THE BASE STAND, THE PISTON WENT UP. SUFFICIENT SPACE CREATED TO ADD SPACER. REMOVED THE LINE SET SNAPPED THE ROSHER PLACED THE FULL 12MM NOZZLE ON THE SYRINGE PLACED THE SPACER INTO THE SYRINGE SCREWED THE SYRINGE ONTO THE GUN DEMONSTRATOR CHECKED THE SYRINGE WAS SCREWED ONTO THE GUN TO MAKE SURE THAT IT WAS ON TIGHT EXTRUSION TIME WAS AT 00:01:30 (1 MINUTE AND 30 SECONDS) THE FIRST CEMENT WAS EXTRUDED ON TO DEMONSTRATORS GLOVE AND IT WAS TACKY, STRUCK TO THE GLOVE THE SCRUB NURSE WAS INJECTING THE MIXED BONE CEMENT INTO A DEMONSTRATION MOULD AND CEMENT WAS INITIALLY BEING DISPENSED - UNKNOWN QUANTITY. THE SCRUB NURSE REPORTED THAT THE BONE CEMENT WAS NOT DISPENSING. J&J MEDTECH SALES STAFF ATTEMPTED TO DISPENSE THE BONE CEMENT BY SQUEEZING THE GUN TRIGGER ON THE SMARTMIX GUN. A BREAKING SOUND WAS HEARD, AND THE SMARTMIX SYRINGE CAME OUT OF THE SMARTMIX GUN. THE TUBE THREAD FRACTURED INTO 3. PIECES PHOTOGRAPHED AND RETAINED. THE PRODUCT WAS NOT RETURNED TO J&J MEDTECH ORTHOPAEDICS; HOWEVER, PHOTOS WERE PROVIDED FOR REVIEW. THE PHOTO INVESTIGATION REVEALED CEMENT INTO THE SYRINGE; HOWEVER, IT IS NOT POSSIBLE TO IDENTIFY THE CONSISTENCY BASED ON THE PROVIDED EVIDENCE. A RETAINED SAMPLE TEST WAS PERFORMED FOR THIS PRODUCT AND LOT COMBINATION. THE CEMENT MIXED AND BEHAVED AS EXPECTED FOR THE PRODUCT TYPE AND MET THE APPROPRIATE CONTROL SPECIFICATION. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE OBSERVED CONDITION OF THE SMARTSET HV BONE CEMENT 40G WOULD NOT 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 J&J MEDTECH ORTHOPAEDICS 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: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 3092040, LOT NUMBER: 4552778, AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. H11 ADDITIONAL NARRATIVE: ADDED: D10 (CONCOMITANT), H4. CORRECTED: D3, D4 (EXPIRY DATE, PRIMARY UDI NUMBER), G1 (MANUFACTURING SITE NAME).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PRODUCT DEMONSTRATION, THE BONE CEMENT WAS NOT DISPENSING, AND THEN THE CEMENT SYRINGE BROKE. CEMENT WAS USED WITH ELECTRIC DEMONSTRATION VACUUM PUMPS. DEMONSTRATOR CHECKED THE SYRINGE WAS SCREWED ONTO THE GUN TO MAKE SURE THAT IT WAS ON TIGHT. THE FIRST CEMENT WAS EXTRUDED ON TO DEMONSTRATORS GLOVE AND IT WAS TACKY AND STRUCK TO THE GLOVE. THE SCRUB NURSE WAS INJECTING THE MIXED BONE CEMENT INTO A DEMONSTRATION MOULD AND CEMENT WAS INITIALLY BEING DISPENSED. THE SCRUB NURSE THEN REPORTED THAT THE BONE CEMENT WAS NOT DISPENSING. THE SALES REPRESENTATIVE ATTEMPTED TO DISPENSE THE BONE CEMENT BY SQUEEZING THE GUN TRIGGER ON THE SMARTMIX GUN. A BREAKING SOUND WAS HEARD, AND THE SMARTMIX SYRINGE CAME OUT OF THE SMARTMIX GUN. THE TUBE THREAD HAD FRACTURED INTO THREE PIECES. EVENT TOOK PLACE IN A NON-CLINICAL SETTING. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2642795 SMARTSET HV BONE CEMENT 40G BONE CEMENT : BONE CEMENT LOD DEPUY CMW - 9610921 4552778 10603295168331

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown