BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SP2 AP CHAMF BLK POPUP R.H.SZ4

    MDR report key: 18237257 · Received November 30, 2023

    Report

    Report Number
    1818910-2023-24366
    Event Type
    Malfunction
    Date Received
    November 30, 2023
    Date of Event
    November 23, 2023
    Report Date
    November 30, 2023
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HTZ
    UDI-DI
    10603295246992
    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, DAMAGED SIGMA SZ4 CHAMFER BLOCK. SEE PHOTOS FOR DETAIL- SMALL KNOB ON TOP CUTTING SLOT GUIDE HAS BROKEN OFF. ALL PIECES RETRIEVED. THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. (B)(4). FW BASE FEMORAL CHAMFER SIZE 4 (PART NO 5415663 JJO 96-6144). THE PHOTO INVESTIGATION REVEALED THAT THE DEVICE 966144, SP2 AP CHAMF BLK POPUP R.H.SZ4 WAS BROKEN AND ONE OF THE SPIKES CAN BE SEEN SEPARATED FROM THE PROVIDED EVIDENCE. BASED ON THE AVAILABLE EVIDENCE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE 966144, SP2 AP CHAMF BLK POPUP R.H.SZ4 WOULD CONTRIBUTE 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 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 : A DEVICE HISTORY RECORD (DHR) REVIEW OR MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT POSSIBLE BECAUSE THE DATE CODE J0802 PROVIDED IS NOT A VALID FINISHED GOODS LOT.

    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.

    Description of Event or Problem · 0

    DAMAGED SIGMA SZ4 CHAMFER BLOCK, THE SMALL KNOB ON TOP OF CUTTING SLOT GUIDE HAS BROKEN OFF. ALL PIECES RETRIEVED. NO DELAY TO SURGERY OR HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2180290 SP2 AP CHAMF BLK POPUP R.H.SZ4 RESECTION BLOCKS/DEVICES HTZ DEPUY ORTHOPAEDICS INC US J0802 10603295246992

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown