BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOSTITCH PRO MENISCAL RPR SYS 0

    MDR report key: 13896528 · Received March 24, 2022

    Report

    Report Number
    3009131204-2022-00008
    Event Type
    Injury
    Date Received
    March 24, 2022
    Date of Event
    March 4, 2022
    Report Date
    January 17, 2024
    Manufacturer
    CETERIX ORTHOPAEDICS, INC
    Product Code
    GAT
    UDI-DI
    00853541006051
    PMA / PMN Number
    K181772
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. THERE WAS A RELATIONSHIP FOUND BETWEEN THE DEVICE AND THE REPORTED EVENT. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTED EVENTS. INSUFFICIENT INFORMATION WAS PROVIDED, THUS A MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. THE INSTRUCTIONS FOR USE WAS REVIEWED AND FOUND TO INCLUDE CONDITIONS OF OFF LABEL USE AND TECHNIQUE SPECIFICS, AS WELL AS PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE AND/OR HARM WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. NO CLINICALLY RELEVANT DOCUMENTATION WAS PROVIDED TO PERFORM A THOROUGH MEDICAL INVESTIGATION. THESE DEVICES ARE MANUFACTURED AND INTENDED AS EXTERNALLY COMMUNICATING DEVICES AND ARE NOT APPROVED FOR LONG-TERM INTERNAL TISSUE EXPOSURE AND LONG-TERM IMPLANTATION. SINCE IT WAS REPORTED THE BREAKAGE OCCURRED IN THE PATIENT¿S JOINT MICROMOTION/MIGRATION IS UNLIKELY. HOWEVER, WE CANNOT MAKE CONCLUSIONS ON THE IMPACT OF THE NON-IMPLANTABLE FOREIGN BODY RETAINED WITHIN THE PATIENT¿S JOINT. SINCE NO OTHER COMPLICATIONS WERE REPORTED, NO FURTHER CLINICAL/MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. SHOULD ANY ADDITIONAL RELEVANT MEDICAL INFORMATION BE DETERMINED, THIS CASE WOULD BE RE-ASSESSED. A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THE LINKAGE TO THE UPPER JAW IS BROKEN. A FUNCTIONAL EVALUATION REVEALED PASS STITCH AND LOWER JAW FUNCTION PROPERLY. THE UPPER JAW LEVER DOES NOT ACTUATE DUE TO BROKEN LINKAGE. THE COMPLAINT WAS CONFIRMED, AND THE ROOT CAUSE WAS ASSOCIATED WITH COMPONENT FAILURE. FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE EXCESSIVE FORCE ON THE DEVICE, ATTEMPTED CORRECTION OF A DAMAGED DEVICE, OR AN INADVERTENT IMPACT EVENT INCONSISTENT WITH NORMAL USE. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR RECOMMENDATIONS ON PROPER USE OF THE DEVICE AND POTENTIAL TROUBLESHOOTING METHODS TO PREVENT FUTURE REOCCURRENCE OF THE REPORTED EVENT. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE NOVOSTITCH UPPER JAW WAS BROKEN IN THE JOINT; IT COULD NOT PASS THE SUTURE. SURGEON CHECKED THE IMAGE IMMEDIATELY AFTER THE SURGERY; THE BROKEN PIECES COULD NOT BE REMOVED FROM THE PATIENT. TWO LOT NUMBERS WERE PROVIDED, FROM WHICH ONLY 1 HAD THE MALFUNCTION (M210133/M210116) BUT IT IS UNKNOWN WHICH ONE HAD THE REPORTED MALFUNCTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1127864 NOVOSTITCH PRO MENISCAL RPR SYS 0 SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT CETERIX ORTHOPAEDICS, INC CTX-A004 UNKNOWN 00853541006051

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other