MAYFIELD BALL SOCKET SWIVEL ADAPTOR

Additional Manufacturer Narrative

UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H6, H11. THE MAYFIELD BALL SWIVEL ADAPTOR (A1064) WAS RETURNED FOR EVALUATION: FAILURE ANALYSIS - THE REPORTED COMPLAINT IS CONFIRMED FROM THE EVALUATION. THE INSPECTION SHOWS IT CANNOT BE ROTATED PROPERLY AND IS SOMEWHAT STIFF, SO IT MUST BE OPENED, CLEANED AND READJUSTED. THE SMALL PARTS, WASHERS AND RETAINING RINGS, MUST BE REPLACED BECAUSE OF WEAR, AND THE SWIVEL HOLDER SHOWS DAMAGED THREAD AND MUST BE REPLACED. THE HOLD DOWN SCREW MUST BE REPLACED WITH THE CURRENT VERSION, AND THE SPRING MUST BE REPLACED FOR PREVENTIVE MAINTENANCE. AS A RESULT, THE UNIT WAS RETURNED UNREPAIRED AND IS NO LONGER ALLOWED TO BE USED FOR MEDICAL PURPOSES. ROOT CAUSE - THE COMPLAINT IS CONFIRMED VIA INSPECTION OF THE UNIT. UNIT HAS LOT CODE 089, INDICATING 2008 MANUFACTURE AND IS BEYOND THE 7 YEAR MAYFIELD EXPECTED LIFE. PROBABLE ROOT CAUSE IS ROUTINE WEAR AND ROUGH HANDLING OF THE UNIT. NO FURTHER INVESTIGATION IS REQUIRED BASED ON THE ACCEPTABILITY OF RISK AND NO ADVERSE TRENDS IDENTIFIED. THIS WILL BE MONITORED AND TRENDED GOING FORWARD. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

Additional Manufacturer Narrative

AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

A FACILITY REPORTED THAT THE MAYFIELD SWIVEL ADAPTOR (A1064) IS MOBILE WHEN IT SHOULD NOT BE - TIGHTENING PROBLEM. THE ISSUE WAS NOTED BEFORE SURGERY WHILE THE PATIENT WAS UNDER ANESTHESIA.