ARTHREX TRIMANO FORTIS

Additional Manufacturer Narrative

THE AFFECTED DEVICE WAS RETURNED TO THE FACTORY AND INVESTIGATED. THIS INVESTIGATION REVEALED THAT DEPOSITS OF A DRIED FLUID AND DETERGENT WERE FOUND INSIDE THE DEVICE. THE MECHANISM INSIDE THE DEVICE WAS CORRODED. THIS CORROSION CAUSED THE JOINTS AND THE RELEASE MECHANISM TO MALFUNCTION. IN THE INSTRUCTIONS FOR USE (IFU) SUITABLE CLEANING AND DISINFECTION PROCEDURES ARE DESCRIBED. THE USER IS WARNED AS FOLLOWS CONCERNING THE RISKS RELATED TO IMPROPER CLEANING: "CAUTION: IMPROPER CLEANING CAN CAUSE PROPERTY DAMAGE! CLEANING AGENT MAY NOT INGRESS INTO JOINTS OR CRACKS. DO NOT USE PRESSURE WASHERS NOR SUBMERGE THE TRIMANO IN LIQUID FOR CLEANING! THE TRIMANO MAY NOT BE SOAKED. ONLY WIPE OFF WITH A DAMP CLOTH!" WE ASSUME THAT A USE ERROR (WRONG CLEANING) IS THE ROOT CAUSE FOR THIS ISSUE. MAQUET GMBH PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. THE EVENT SITE NAME IS (B)(6).

Description of Event or Problem

MANUFACTURER REFERENCE # (B)(4).

Additional Manufacturer Narrative

AT THE TIME OF THIS REPORT THE INVESTIGATION WAS STILL ONGOING. AS SOON AS THE INVESTIGATION IS FINISHED THE REPORT WILL BE UPDATED AND A FOLLOW-UP/FINAL REPORT WILL BE PROVIDED TO THE FDA. GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET GMBH, KEHLER STRASSE 31, RASTATT, GERMANY 76437. EXEMPTION # E2018004. GETINGE USA SALES, LLC, 45 BARBOUR POND DRIVE, WAYNE, NJ 07470. CONTACT PERSON: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THE HANDLE OF THE TRIMANO FORTIS WAS STICKY. THAT IS WHY THE TRIMANO ARM WAS STUCK DURING A SURGERY AND COULD NOT BE MOVED. AFTER DEPRESSING THE HANDLE FOR SEVERAL MINUTES IT STARTED TO WORK AGAIN. THE SURGERY PROCEEDED AND WAS COMPLETED AFTER A 15 MINUTE DELAY WITH THE SAME PRODUCT. NO PATIENT INJURY WAS REPORTED. (B)(4).