BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN MCP IMPL

    MDR report key: 19235707 · Received May 2, 2024

    Report

    Report Number
    3002788818-2024-00064
    Event Type
    Injury
    Date Received
    May 2, 2024
    Date of Event
    February 28, 2024
    Report Date
    May 27, 2024
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    OMX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10. INTERNAL REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    H3, H6: THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT HUMAN ERROR IS THE CLINICAL ROOT CAUSE OF THE POSTPONED IMPLANTATION. THE AVAILABILITY OF THE IMPLANTS SHOULD BE CONFIRMED BEFORE SURGERY. DEVICE SPECIFIC IDENTIFIERS WERE NOT PROVIDED. THEREFORE, AN EVALUATION OF THE MANUFACTURING RECORDS, COMPLAINT HISTORY REVIEW, RISK MANAGEMENT FILE AND PRIOR ACTIONS REVIEW COULD NOT BE PERFORMED. A REVIEW OF INSTRUCTIONS FOR USE DOCUMENT FOR PYROTITAN¿ HUMERAL RESURFACING ARTHROPLASTY (HRA) REVEALED THAT A SURGICAL TECHNIQUE BROCHURE IS AVAILABLE WHICH OUTLINES THE BASIC PROCEDURE FOR DEVICE IMPLANTATION AND THE USE OF SPECIALIZED SURGICAL INSTRUMENTATION. IT IS THE RESPONSIBILITY OF THE SURGEON TO BE FAMILIAR WITH THE PROCEDURE BEFORE USE OF THESE PRODUCTS. THIS HAS BEEN IDENTIFIED IN THE SURGICAL PROCEDURE SECTION. AT THIS TIME, WE HAVE NO EVIDENCE TO CONCLUDE THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. FACTORS THAT COULD CONTRIBUTE TO THE REPORTED EVENT INCLUDE SURGICAL SET-UP PREPARATION ERRORS. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, ON THE DAY OF A HAND SURGERY, A PYROCARBON MCP JOINT IMPLANT WAS NOT AVAILABLE FOR THE PROCEDURE. ACCORDING TO THE HOSPITAL, THE SURGEON WAS NOT ADVISED THAT THE COMPONENT WAS NOT AVAILABLE UNTIL AFTER THE PATIENT WAS GIVEN ANESTHESIA. SURGEON WENT FORWARD WITH TWO OTHER ASPECTS OF SURGERY. THE S+N PRODUCT WAS NOT IMPLANTED. THE PATIENT WAS REPORTED TO BE HEALING. IT IS ANTICIPATED THAT THEY WILL UNDERGO ADDITIONAL SURGERY USING THE S+N IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919652 UNKN MCP IMPL HIGH DEMAND, REVISION, SEMI-CONSTRAINED, PYROLYTIC CARBON, UNCEMENTED FINGER PRO OMX ASCENSION ORTHOPEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other