NA

Description of Event or Problem

The user facility reported that during a patient procedure, their Armboard with Gravity Latch broke off and fell. No report of injury or procedure delay.

Additional Manufacturer Narrative

The device subject of the reported event was not returned for evaluation; however, pictures of the device were provided by user facility personnel.After further investigation of pictures, STERIS observed that the metal rotation mechanism of the Armboard with Gravity Latch was broken. This damage is indicative of excess force by user facility personnel.The Armboard with Gravity Latch Instructions for Use states, "WARNING - PERSONAL INJURY AND/OR EQUIPMENT DAMAGE HAZARD: - To prevent armboard or table damage, ensure armboard is not installed or moved parallel to table side rails. This orientation results in damage to armboard and/or table during table articulations."The user facility was provided with a replacement Armboard with Gravity Latch.A STERIS Account Manager performed in-service training on the proper use and operation of the Armboard with Gravity Latch, specifically on the safety warnings.No additional issues have been reported.UDI RELATED DATA CLARIFICATION - The manufacture date was not provided; therefore, the applicable production identifiers were not included in the MDR.