MAYFIELD ULTRA BASE UNIT

Description of Event or Problem

THIS REPORT IS 3 OF 3 AND LINKED TO MFG REPORT NUMBERS 3004608878-2025-00044 AND 3004608878-2025-00049: A FACILITY REPORTED THAT THE MAYFIELD ULTRA BASE UNIT (A2101) IS MOBILE WHEN IT SHOULD NOT BE - TIGHTENING PROBLEM. THE ISSUE WAS NOTED BEFORE SURGERY WHILE THE PATIENT WAS UNDER ANESTHESIA. THERE WAS NO PATIENT INJURY AND NO INCREASED SURGERY TIME.

Additional Manufacturer Narrative

THE MAYFIELD MODIFIED ULTRA BASE UNIT (A2101) WAS RETURNED FOR EVALUATION: DEVICE HISTORY RECORD (DHR) - THE DHR WAS REVIEWED AND SHOWS NO ABNORMALITIES RELATED TO THE REPORTED FAILURE. FAILURE ANALYSIS - INVESTIGATION OF THE RETURNED UNIT SHOWS THAT THE 6-INCH TRANSITIONAL MEMBER HAS DAMAGED STARBURST TEETH, THE ADJUSTING WRENCH THREAD IS BROKEN, AND THE WRENCH NEEDS TO BE REPLACED. ADDITIONALLY, THE HANDLE ASSEMBLY'S SHOCK CUSHION AND THE CAM LINK SUPPORT PIN WERE REMOVED AND MUST BE REPLACED. TO RESOLVE ALL ISSUES, THE FOLLOWING WERE REPLACED: THE TRANSITIONAL MEMBER; THE ADJUSTMENT WRENCH; THE BASE HANDLE ASSEMBLY¿S SHOCK CUSHION AND ITS CAM LINK SUPPORT PIN; AND THE HANDLE ASSEMBLY WAS REASSEMBLED AND ADJUSTED TO BUILD UP THE REQUIRED PRESSURE ONTO THE TRANSITIONAL MEMBER. AFTER COMPLETING THE REPAIR, THE UNIT SUCCESSFULLY PASSED THE FUNCTION TEST. ROOT CAUSE - THE COMPLAINT IS CONFIRMED VIA INSPECTION OF THE UNIT. THE PROBABLE ROOT CAUSE IS MISHANDLING AND IMPROPER DISASSEMBLY OF THE UNIT. ADDITIONALLY, THIS UNIT IS BEYOND INTEGRA¿S 7 YEARS RECOMMENDED LIFE CYCLE (MANUFACTURED IN 2007). NO FURTHER INVESTIGATION IS REQUIRED BASED ON THE ACCEPTABILITY OF RISK AND NO ADVERSE TRENDS WERE IDENTIFIED. THIS WILL BE MONITORED AND TRENDED GOING FORWARD. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.