PRIMUSRS

Additional Manufacturer Narrative

BTE PERFORMED AN ANALYSIS REVIEWING THE SHAFT FAILURE CONDITIONS. INSPECTION OF CROSS-SECTIONS OF THE LOAD CELL SHAFTS UNCOVERED THAT THE SHAFT WILL NOT BE ABLE TO WITHSTAND THE RATED LOADS ONLY WHEN A UNIQUE AND RARE SET OF MANUFACTURING CONDITIONS ARE ENCOUNTERED. THE POSSIBILITY OF THESE CONDITIONS OCCURRING ONLY EXISTS ON A SMALL SUBSET OF SHAFTS. THE PROBABILITY THAT A SHAFT WILL FRACTURE OR SEPARATE IS REMOTE.

Description of Event or Problem

PRIMUS LOAD CELL SHAFT FRACTURED AND SEPARATED WHILE PATIENT WAS EXERCISING ON THE PRIMUS. NO INJURY OCCURED.

Additional Manufacturer Narrative

NO INJURY RELATED TO THE SHAFT ISSUE HAS BEEN REPORTED. DESPITE THE DEVICE MALFUNCTIONING, BASED ON THE DESIGN OF THE PRIMUS AND THE NATURE OF THE FRACTURE, EVIDENCE SHOWS THAT A PATIENT OR USER WILL BE AT MINIMAL RISK FOR INJURY. BTE PERFORMED AN ANALYSIS REVIEWING THE SHAFT FAILURE CONDITIONS. INSPECTION OF CROSS-SECTIONS OF THE LOAD CELL SHAFTS REVEALED THAT THE SHAFT WILL WITHSTAND THE RATED LOADS UNLESS A UNIQUE AND RARE SET OF MANUFACTURING CONDITIONS ARE ENCOUNTERED. THE POSSIBILITY OF THESE CONDITIONS OCCURRING ONLY EXISTS ON A SMALL SUBSET OF SHAFTS. THE PROBABILITY THAT A SHAFT WILL FRACTURE OR SEPARATE IS REMOTE. IT HAS BEEN DETERMINED THAT NO REMEDIAL ACTION IS NECESSARY. REF. H3: THE LOAD CELL SHAFT FROM THE REPORTER FACILITY'S DEVICE HAS BEEN EVALUATED BASED ON EVIDENCE PROVIDED BY THE USER. THERE WAS NO NEED TO INSPECT THE ENTIRE PRIMUS SYSTEM ON THE USER SITE. SHAFTS FROM INVENTORY AND SHAFTS FROM OTHER DISTRIBUTED SYSTEMS HAVE BEEN ALSO EVALUATED. SUSPECT SHAFTS UNDERWENT LOAD TESTING AT BTE, AND ALL PARTS PASSED THE TEST.