MAYFIELD SWIVEL ADAPTOR A1018

Description of Event or Problem

THIS REPORT IS 3 OF 3 AND LINKED TO MFG REPORT NUMBER 3004608878-2026-00072 AND 3004608878-2026-00073: A FACILITY REPORTED THAT THE PATIENT'S HEAD SLIPPED AFTER BEING POSITIONED IN THE MAYFIELD SWIVEL ADAPTOR (A1018) WHICH RESULTED IN LACERATION AT THE PIN SITE ABOUT 2CM LONG. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

Additional Manufacturer Narrative

THE MAYFIELD SWIVEL ADAPTOR (A1018) WAS RETURNED FOR EVALUATION: DEVICE HISTORY RECORD (DHR) REVIEW - THE DHR WAS REVIEWED AND SHOWS NO ABNORMALITIES RELATED TO THE REPORTED FAILURE. FAILURE ANALYSIS - INVESTIGATION OF THE RETURNED UNIT WAS UNABLE TO DUPLICATE SLIPPAGE AND PASSES ALL SPECIFIC FUNCTIONAL TESTING. THE UNIT WAS PURCHASED IN (B)(6) 2024 AND HAS NOT BEEN SERVICED SINCE; THEREFORE, IT IS STRONGLY RECOMMENDED THAT A PREVENTIVE MAINTENANCE (PM) BE PERFORMED AT THIS TIME. FURTHER, SINCE A PATIENT INJURY WAS INVOLVED, THE UNIT WAS SENT TO QUALITY ENGINEERING (QE) FOR FURTHER INVESTIGATION. QE CONFIRMED THE INITIAL FINDINGS OF THE SERVICE TEAM WITH THE OBSERVATION THAT THE UNIT WAS IN WORN CONDITION. TO RESOLVE THE OBSERVED ISSUES, ALL WORN COMPONENTS WILL BE REPLACED ALONG WITH GENERAL MAINTENANCE AND CLEANING. ROOT CAUSE - THE COMPLAINT IS NOT CONFIRMED FOR SLIPPAGE. THE UNIT PASSES ALL SPECIFIC FUNCTIONAL TESTING, AND THE PROBABLE ROOT CAUSE OF THE REPORTED COMPLAINT IS IMPROPER OR SUBOPTIMAL POSITIONING OF THE SKULL CLAMP ON THE PATIENT. 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.