BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATT THEMIS BAL TIB TOWER LT

    MDR report key: 22158537 · Received June 6, 2025

    Report

    Report Number
    1818910-2025-09226
    Event Type
    Malfunction
    Date Received
    June 6, 2025
    Date of Event
    May 14, 2025
    Manufacturer
    DEPUY IRELAND - 3015516266
    Product Code
    HWT
    UDI-DI
    10603295496977
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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). INVESTIGATION SUMMARY : IT WAS REPORTED THAT PIECE WAS NOT CATCHING ON THE GROOVES, IT JUST CONTINUES TO MOVE FREELY AND WILL NOT GRASP AT A DETERMINED THICKNESS. IT DID NOT HAPPEN IN SURGERY. THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE ATT THEMIS BAL TIB TOWER LT HAD SIGNS OF REPEATED USE. NO DAMAGE THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT WAS FOUND. A FUNCTIONAL TEST WAS NOT PERFORMED SINCE THE MATING DEVICE WAS NOT RETURNED, NO JAMMED CONDITION WAS FOUND, HOWEVER, LEVER WAS OBSERVED TO BE SLIGHTLY LOOSE. IT IS SUSPECTED THAT THIS CONDITION WOULD LIKELY IMPEDE THE DEVICE FROM SECURELY ATTACH OR HOLDING ITS MATING DEVICE. THEREFORE, THE REPORTED ALLEGATION CAN BE CONFIRMED. 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 NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE ATT THEMIS BAL TIB TOWER LT WOULD HAVE CONTRIBUTED TO THE COMPLAINED 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: 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. CORRECTED: H3.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PIECE WAS NOT CATCHING ON THE GROOVES, IT JUST CONTINUES TO MOVE FREELY AND WILL NOT GRASP AT A DETERMINED THICKNESS. IT DID NOT HAPPEN IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719693 ATT THEMIS BAL TIB TOWER LT SIZING/MEASURING INSTRUMENTS HWT DEPUY IRELAND - 3015516266 CV191520 10603295496977

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown