BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFC TB TRY TRL FIX PIN LG (4EA

    MDR report key: 20547014 · Received October 28, 2024

    Report

    Report Number
    1818910-2024-22475
    Event Type
    Malfunction
    Date Received
    October 28, 2024
    Date of Event
    September 26, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LXH
    UDI-DI
    10603295216117
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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. H3, H6: PHOTO INVESTIGATION SUMMARY: THE PRODUCT WAS NOT RETURNED TO MEDTECH ORTHOPAEDICS, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. THE PHOTO INVESTIGATION REVEALED THAT [860590 , PFC TB TRY TRL FIX PIN LG (4EA ] HAS BENT AND BROKEN . THE OBSERVED CONDITION OF THE DEVICE WAS CONSIST WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED USER ERROR. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE [PFC TB TRY TRL FIX PIN LG (4EA ] WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, C UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT AND 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 COMPLAINT CONDITION. AS PART OF 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SURGERY, THE THE FEMORAL AND TIBIAL FIXATION PINS WERE VERY TWISTED AND THE SURGEON HAD TO WORK WITH THEM IN THAT STATE. IN ADDITION TO THIS, ONE OF THE IMPACTOR HANDLES WAS DISASSEMBLED. THE FRAGMENTS WERE REMOVED AND THE OTHER IMPACTOR HANDLE THAT COMES WITH THE EQUIPMENT WAS USED TO GIVE A PROMPT SOLUTION TO THIS NOVELTY TO THE SURGEON, BUT EVEN SO ALL THIS GENERATED DISCOMFORT IN THE SPECIALIST; HOWEVER, THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT AFFECTING THE PATIENT AND WITHOUT ALTERATIONS IN THE SURGICAL TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1781705 PFC TB TRY TRL FIX PIN LG (4EA KNEE INSTRUMENT : FIXATION PINS LXH DEPUY ORTHOPAEDICS INC US TBLRC 10603295216117

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown