BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA HP UNI FEM FIN BLK SZ 2

    MDR report key: 20673514 · Received November 13, 2024

    Report

    Report Number
    1818910-2024-23622
    Event Type
    Malfunction
    Date Received
    November 13, 2024
    Date of Event
    October 28, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HWT
    UDI-DI
    10603295083764
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, "SURGEON ATTEMPTED TO USE CHISEL IN CUTTING BLOCK AS PER OPERATION TECHNIQUE BUT RECOGNIZED 2X CUTTING BLOCKS WERE FAULTY AND USED ALTERNATIVE METHOD AS SUGGESTED IN OPTECH. I WAS ABLE TO GAIN ACCESS TO INSTRUMENTS WHERE I WAS ABLE TO CONFIRM THAT CUTTING BLOCKS ARE DAMAGED BEYOND STATE OF ADEQUATE AND APPROPRIATE USE." THE PRODUCT WAS NOT RETURNED TO MEDTECH ORTHOPAEDICS; HOWEVER, PHOTOS WERE PROVIDED FOR REVIEW. (B)(4). THE PHOTO INVESTIGATION REVEALED THAT '202471200, SIGMA HP UNI FEM FIN BLK SZ 2' HAD STRIPPED. THIS TYPE OF DAMAGE IS CONSISTENT WITH OTHER TOOLS AND HARD EDGES COMING IN CONTACT WITH THE DEVICE, PROPERLY HANDLING AND ATTENTION TO THE APPROVED USE OF THE DEVICE DIMINISHES THE RISK OF FAILURE. THE PROVIDED EVIDENCE WAS NOT SUFFICIENT TO CONFIRM THE REPORTED EVENT OF UNABLE TO ASSEMBLE. FUNCTIONALITY ISSUES CANNOT BE EVALUATED THROUGH A PHOTO INVESTIGATION. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE SIGMA HP UNI FEM FIN BLK SZ 2 WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, 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 IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY ORTHOPAEDICS IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY ORTHOPAEDICS HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY ORTHOPAEDICS OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY ORTHOPAEDICS, 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH 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 WHICH 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. 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 THE SURGEON ATTEMPTED TO USE CHISEL IN CUTTING BLOCK AS PER OPERATION TECHNIQUE BUT RECOGNIZED 2X CUTTING BLOCKS WERE FAULTY AND USED ALTERNATIVE METHOD AS SUGGESTED IN OPTECH. IT WAS CONFIRMED THAT CUTTING BLOCKS ARE DAMAGED BEYOND STATE OF ADEQUATE AND APPROPRIATE USE. THE NOTCH WHERE THE CHISEL IS INSERTED IS DAMAGED, PREVENTING THE CHISEL FROM ENTERING. THE DAMAGED ASPECT IS THE SMALL PROTRUDING METAL PIECE WITHIN THE CHISEL SLOT. THE CHISEL HAS A RAISED ASPECT THAT IS DESIGNED TO RUN ALONG THE PROTRUDING METAL PIECE. IN BEING DAMAGED, THIS IS PREVENTING ACCESS. THERE WAS NO HARM TO THE PATIENT. THE SURGEON RECOGNIZED DAMAGED AND USED ALTERNATIVE APPROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2481364 SIGMA HP UNI FEM FIN BLK SZ 2 KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES HWT DEPUY ORTHOPAEDICS INC US A1009 10603295083764

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown