AMIS 01.15.10.0226 CFIBER BOARD HINGE

Additional Manufacturer Narrative

ON JUNE 03RD 2024 WE HAVE RECEIVED THE ITEM FOR INSPECTION. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER. THE CFIBER TABLE HINGE WAS ROTATED BACKWARD REMAINING UNDER THE OPERATING TABLE. AS SOON AS THE OPERATING COLUMN WAS ACTIVATED AND GONE UP, IT TOUCHED THE HINGE OF THE CFIBER BOARD, WHICH WAS BETWEEN THE OPERATING TABLE AND THE COLUMN, PUSHING THE CFIBER BOARD AND CAUSING THE PATIENT TO FALL. THE CFIBER BOARD HINGE MUST BE MOUNTED WITH THE AMIS LEG POSITIONER AND THE CORRECT POSITION IS STRAIGHT FORWARD, AS STATED IN THE INSTRUCTIONS FOR USE. PROBABLY THE CFIBER HINGE BOARD WAS PLACED UNDER THE OPERATING TABLE TO AVOID ANY CONTACT WHEN TRANSPORTING THE PATIENT INTO THE HOSPITAL BEFORE SURGERY AND MISTAKENLY LEFT UNDER THE OPERATING TABLE. THE USER SHOULD BE CAREFUL BEFORE CONNECTING THE COLUMN TO THE OPERATING TABLE, CHECKING WHETHER ANY EXTERNAL PART CREATES IMPEDIMENTS THAT COMPROMISE THE PROPER CONNECTION BETWEEN THE PARTS. THE HINGE OF THE CFIBER BOARD RECEIVED FOR ANALYSIS IS FUNCTIONAL.

Description of Event or Problem

THE SURGERY OPERATING TABLE COLUMN (THE PART SUPPORTING THE OPERATING TABLE POSITIONED ON THE OR FLOOR) WENT IN IMPINGEMENT WITH THE HINGE OF THE UNIVERSAL TABLE FOR AMIS CFIBER BOARD. THE HINGE OF THE UNIVERSAL TABLE FOR AMIS CFIBER BOARD WAS POSITIONED UNDER THE CFIBER BOARD AND LEFT ERRONEUSLY BETWEEN THE OPERATING TABLE AND THE COLUMN OF THE OR TABLE. THIS CAUSED THE TABLE TO TILT AND THE PATIENT FELL OFF THE OPERATING TABLE AND FRACTURED SEVERAL RIBS.

Description of Event or Problem

THE SURGERY OPERATING TABLE COLUMN (THE PART SUPPORTING THE OPERATING TABLE POSITIONED ON THE OR FLOOR) WENT IN IMPINGEMENT WITH THE HINGE OF THE UNIVERSAL TABLE FOR AMIS CFIBER BOARD. THE HINGE WAS POSITIONED BETWEEN THE OPERATING TABLE AND THE COLUMN OF THE OR TABLE FOR ERROR BY OR STAFF. THIS CAUSED THE TABLE TO TILT AND THE PATIENT FELL OFF THE OPERATING TABLE AND FRACTURED SEVERAL RIBS.

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 2 MAY 2024. LOT 2156821: (B)(4) MANUFACTURED AND RELEASED ON 05-JAN-2022. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT DURING THE PERIOD OF REVIEW ANALYSIS PERFORMED BY R&D MANAGER: THE CFIBER BOARD HINGE WAS ROTATED BACKWARDS BETWEEN THE COLUMN AND THE OPERATORY TABLE; THE ROOT CAUSE IS LIKELY RELATED TO THE SPECIFIC CONDITIONS OF THE SURGICAL APPLICATION. THE HINGE WAS NOT IN THE RIGHT POSITION. THE ASSEMBLY PROCEDURE OF THE CFIBER BOARD IS DESCRIBED IN THE IFU WHERE THE RIGHT POSITION OF THE HINGE IS SHOWN ALSO TO CONNECT THE LEG POSITIONER.

Additional Manufacturer Narrative

CORRECTION OF THE DEVICE DATE RETURNED (03-JUNE-2024).

Description of Event or Problem

THE SURGERY OPERATING TABLE COLUMN (THE PART SUPPORTING THE OPERATING TABLE POSITIONED ON THE OR FLOOR) WENT IN IMPINGEMENT WITH THE HINGE OF THE UNIVERSAL TABLE FOR AMIS CFIBER BOARD. THE HINGE OF THE UNIVERSAL TABLE FOR AMIS CFIBER BOARD WAS POSITIONED UNDER THE CFIBER BOARD AND LEFT ERRONEUSLY BETWEEN THE OPERATING TABLE AND THE COLUMN OF THE OR TABLE. THIS CAUSED THE TABLE TO TILT AND THE PATIENT FELL OFF THE OPERATING TABLE AND FRACTURED SEVERAL RIBS.