ZERO GRAVITY HINGED MONORAIL SYSTEM

Additional Manufacturer Narrative

H3 SUMMARY: DEVICE IS NOT AVAILABLE FOR EVALUATION. THIS MALFUNCTION WAS INITIALLY REPORTED TO THE DISTRIBUTOR, BIOTRONIK. IT WAS REPORTED THAT THE SCREWS ON THE RAIL WERE LOOSE OR MISSING. THERE WAS NO PATIENT OR CAREGIVER INJURY REPORTED AS A RESULT OF THIS EVENT. IT IS BELIEVED THAT THE UNIT HAS BEEN TAKEN OUT OF USE. THE ROOT CAUSE IS UNKNOWN AT THIS TIME. THERE IS NO APPARENT REASON THAT THE SCREWS SHOULD HAVE BEEN LOOSE. THE PREVENTIVE MAINTENANCE CHECKLIST FOR THIS DEVICE PROVIDES INSTRUCTIONS FOR LOOSE COMPONENT AND FASTENER TIGHTNESS CHECK. IT IS RECOMMENDED THAT PREVENTIVE MAINTENANCE BE PERFORMED ON THIS DEVICE ANNUALLY. THE COMPLAINT UNIT WAS MANUFACTURED AND SHIPPED IN JUNE OF 2022 AND WAS APPROXIMATELY 19 MONTHS OLD AT THE TIME THAT THE COMPLAINT WAS DOCUMENTED. THE CUSTOMER WAS CONTACTED FOR ADDITIONAL INFORMATION REGARDING MAINTENANCE AND USAGE OF THE DEVICE, BUT NO ADDITIONAL INFORMATION HAS BEEN RECEIVED SO FAR. CURRENTLY, THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT, AND THE INSTRUCTIONS FOR USE WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED, AND ACTED UPON AS WARRANTED. MANUFACTURER REFERENCE FILE: (B)(4).

Description of Event or Problem

TIDI WAS CONTACTED BY BIOTRONIK, THE EUROPEAN DISTRIBUTOR FOR ZERO GRAVITY, TO PROVIDE INFORMATION ON BALANCER SCREWS. THEY RECEIVED A SERVICE REQUEST TO REPLACE 4 SCREWS. ADDITIONAL INFORMATION FROM CUSTOMER EMAIL: SOME SCREWS FROM THE BALANCER IN BERLIN CHARITE ARE LOOSE AND TWO ARE MISSING.