BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOSTITCH PRO MEN RPR SYS 2-0

    MDR report key: 10342018 · Received July 29, 2020

    Report

    Report Number
    3009131204-2020-00018
    Event Type
    Injury
    Date Received
    July 29, 2020
    Date of Event
    July 9, 2020
    Report Date
    October 19, 2020
    Manufacturer
    CETERIX ORTHOPAEDICS, INC
    Product Code
    GAT
    UDI-DI
    00853541006112
    PMA / PMN Number
    K180531
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H2, H3, H6: VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED BECAUSE THE DEVICE, USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION. THUS, THE COMPLAINT COULD NOT BE VERIFIED AND A ROOT CAUSE COULD NOT BE DETERMINED WITH CONFIDENCE THE UPPER JAW HINGE CAN BREAK WHEN EXCESSIVE FORCE IS APPLIED DURING USE, IF THE PORTAL PLACEMENT IS LOW, OR JAMMING THE DEVICE IN AND OUT OF THE KNEE OR INTO THE STRUCTURES IN KNEE. THE PROBABLE ROOT CAUSE FOR THE UPPER JAW HINGE TO BREAK COULD BE DUE TO TORQUEING THE DEVICE EXCESSIVELY AND PLACING TOO MUCH FORCE ON THE HINGE AND UPPER JAW. THE INSTRUCTION FOR USE CONTAINS PRECAUTIONS ABOUT USING OF THE DEVICE UNDER THESE CONDITIONS. THE RISK MANAGEMENT DOCUMENTATION WAS REVIEWED AND FOUND TO CONTAIN THIS FAILURE MODE WITHIN THE RISK FILE, NO UPDATES ARE REQUIRED. THE INSTRUCTION FOR USE OUTLINES PRECAUTIONARY STATEMENTS AND INSTRUCTIONS IN REGARDS TO THE USE OF THE DEVICE TO AVOID DAMAGE OR NON-FUNCTIONALITY. A REVIEW OF THE COMPLAINT AND MANUFACTURING RECORDS WAS PERFORMED AND THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Additional Manufacturer Narrative · 0

    H10. H3, H6: LOT M190091, ONE DEVICE, USED IN TREATMENT, WAS RETURNED FOR EVALUATION. THERE WAS RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. UPON INVESTIGATION, IT WAS DETERMINED THAT THE UPPER JAW HINGE HAD BROKEN. IF THE HINGE IS BROKEN, THE ORANGE TRIGGER CAN NO LONGER CONTROL THE UPPER JAW AND THE SURGEON WILL HAVE INCOMPLETE STITCH. ALL PARTS OF THE DEVICE REMAINED ATTACHED TO THE DEVICE, NO FRAGMENTS WERE NOTED MISSING. THE UPPER JAW HINGE CAN BREAK WHEN EXCESSIVE FORCE IS APPLIED DURING USE, IF THE PORTAL PLACEMENT IS LOW, OR JAMMING THE DEVICE IN AND OUT OF THE KNEE OR INTO THE STRUCTURES IN KNEE. THE PROBABLE ROOT CAUSE FOR THE UPPER JAW HINGE TO BREAK COULD BE DUE TO TORQUING THE DEVICE EXCESSIVELY AND PLACING TOO MUCH FORCE ON THE HINGE AND UPPER JAW. THERE WERE NO INDICATIONS DURING MANUFACTURING RECORD REVIEW THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE REPORTED PRELOADED SUTURE PASSER PERFORMED THERE ARE NO INDICATIONS TO SUGGEST THAT THE DEVICE/PRODUCT DID NOT MEET SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. A REVIEW OF THE COMPLAINT HISTORY FOR LOT NUMBER FOUND NO SIMILAR EVENTS PRIOR TO THE COMPLAINT EVENT. RISK MANAGEMENT DOCUMENTS WERE REVIEWED FINDING NO ADDITIONAL RISKS THAT REQUIRE TO BE ADDED TO THE REFERENCE DOCUMENT. THE INSTRUCTION FOR USE ("IFU") DISCUSSES ALL SURGICAL HAZARDS IN WARNING SECTION. IN IFU WARNING NOTES, ¿DO NOT FORCE THE DEVICE INTO TIGHT JOINT SPACES. EXCESSIVE PUSHING, TWISTING OR LEVERING MAY CAUSE BREAKAGE.¿ THERE ARE NO INDICATIONS TO SUGGEST THAT THE DEVICE/PRODUCT DID NOT MEET SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Additional Manufacturer Narrative · 0

    LOT M190091, ONE DEVICE, USED IN TREATMENT, WAS RETURNED FOR EVALUATION. THERE WAS RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. UPON INVESTIGATION, IT WAS DETERMINED THAT THE UPPER JAW HINGE HAD BROKEN, THE BROKEN PIECE OF HINGE WAS RETRIEVED DURING SURGERY. IF THE HINGE IS BROKEN, THE ORANGE TRIGGER CAN NO LONGER CONTROL THE UPPER JAW AND THE SURGEON WILL HAVE INCOMPLETE STITCH. ALL PARTS OF THE DEVICE REMAINED ATTACHED TO THE DEVICE, NO FRAGMENTS WERE NOTED MISSING. THE UPPER JAW HINGE CAN BREAK WHEN EXCESSIVE FORCE IS APPLIED DURING USE, IF THE PORTAL PLACEMENT IS LOW, OR JAMMING THE DEVICE IN AND OUT OF THE KNEE OR INTO THE STRUCTURES IN KNEE. THE PROBABLE ROOT CAUSE FOR THE UPPER JAW HINGE TO BREAK COULD BE DUE TO TORQUEING THE DEVICE EXCESSIVELY AND PLACING TOO MUCH FORCE ON THE HINGE AND UPPER JAW. THERE WERE NO INDICATIONS DURING MANUFACTURING RECORD REVIEW THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE REPORTED PRELOADED SUTURE PASSER PERFORMED THERE ARE NO INDICATIONS TO SUGGEST THAT THE DEVICE/PRODUCT DID NOT MEET SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. A REVIEW OF THE COMPLAINT HISTORY FOR LOT NUMBER FOUND NO SIMILAR EVENTS PRIOR TO THE COMPLAINT EVENT. RISK MANAGEMENT DOCUMENTS WERE REVIEWED FINDING NO ADDITIONAL RISKS THAT REQUIRE TO BE ADDED TO THE REFERENCE DOCUMENT. THE INSTRUCTION FOR USE ("IFU") DISCUSSES ALL SURGICAL HAZARDS IN WARNING SECTION. IN IFU WARNING NOTES, ¿DO NOT FORCE THE DEVICE INTO TIGHT JOINT SPACES. EXCESSIVE PUSHING, TWISTING OR LEVERING MAY CAUSE BREAKAGE.¿ THERE ARE NO INDICATIONS TO SUGGEST THAT THE DEVICE/PRODUCT DID NOT MEET SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON USED NOVOSTITCH TO PASS 3 HAYBAIL STITCHES; UPON TAKING THE PASSER OUT OF THE JOINT ON THE 3RD TIME IT WAS NOTICED THERE WAS A PIECE OF METAL IN THE JAW. THE PIECE THAT HOLDS THE SHAFT AND JAW TOGETHER ON GUN IS ALSO BROKEN. PIECES WERE REMOVED WITH A GRASPER. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY REPORTED. NO OTHER PATIENT COMPLICATION WAS REPORTED AND THE PATIENT OUTCOME IS STILL UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806455 NOVOSTITCH PRO MEN RPR SYS 2-0 SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT CETERIX ORTHOPAEDICS, INC CTX-A003 M190091 00853541006112

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention