BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA HP UNI ANTERIOR CHISEL

    MDR report key: 12121540 · Received July 6, 2021

    Report

    Report Number
    1818910-2021-14326
    Event Type
    Injury
    Date Received
    July 6, 2021
    Date of Event
    June 16, 2021
    Report Date
    June 16, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    FZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE WAS RECEIVED FOR EXAMINATION, THEREFORE THE REPORTED EVENT COULD NOT BE CONFIRMED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION (MRE), WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.

    Description of Event or Problem · 0

    PRODUCT AND LOT NUMBER OF THE REPORTED DEVICES (ANTERIOR CHAMFER OSTEOTOME AND FEMORAL PREP BLOCK) 2024-71-500 AND 2024-85-000. WAS THERE ANY ALLEGED DEFICIENCY TO THE REPORTED DEVICES? IF YES, PLEASE PROVIDE DETAILS. NO. PLEASE VERIFY IF THE INSTRUMENT USED DURING SURGERY? YES FEMORAL FINISHING BLOCK AND ANTERIOR CHISEL. IF YES, WAS THERE SURGICAL DELAY? YES. WHAT WAS THE DURATION OF THE DELAY? 10 MINUTES WHILST THEY INSERTED A SCREW. THE HOSPITAL WILL NOT RELEASE THE INSTRUMENTATION UNTIL WE CAN PROVIDE REPLACEMENTS SO THAT SCHEDULING AND THEATRE LISTS ARE NOT IMPACTED.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MALE RIGHT MEDIAL UNI HAD A MEDIAL FACET FRACTURE OF THE TROCHLEA AND A SCREW WAS REQUIRED TO CONTAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017192 SIGMA HP UNI ANTERIOR CHISEL KNEE INSTRUMENT : CUTTING INSTRUMENTS FZO DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention