MAYFIELD SWIVEL HORSESHOE HEADREST

Additional Manufacturer Narrative

UPDATED FIELDS: ADDITIONAL INFORMATION RECEIVED AS FOLLOWS: 1. CAN YOU PLEASE CONFIRM THE TYPE OF PROCEDURE THE DEVICE WAS USED? ANSWER: SPINAL FUSION SURGERY. 2. WAS THERE A DELAY IN SURGERY DUE TO PRODUCT PROBLEM? IF YES, HOW LONG (IN MINUTES)? ANSWER: THE ONLY DELAY WAS TO RETRIEVE ANOTHER HORSESHOE FROM THE SUPPLY ROOM, LESS THAN 4 MINUTES. 3. HOW WAS THE PATIENT INITIALLY POSITIONED FOR THE SURGERY? ANSWER: SUPINE. 4. WAS THE PATIENT REPOSITIONED AT ANY TIME DURING THE SURGERY? IF YES, EXPLAIN HOW THE PATIENT¿S POSITION HAD CHANGED AFTER INITIAL POSITIONING HAD BEEN COMPLETED? ANSWER: NO, THE PATIENT WAS NOT REPOSITIONED BEFORE THE INCIDENT OCCURRED. IT OCCURRED AS THE PATIENT WAS TRANSFERRED ONTO THE OR TABLE, BEFORE FINAL POSITIONING AND DRAPING.

Description of Event or Problem

N/A

Description of Event or Problem

A FACILITY REPORTED THAT THE MAYFIELD SWIVEL HORSESHOE HEADREST (A1012) FAILED DURING USE. THE PIN HOLDING THE SQUARE SHAFT IN PLACE FELL OUT OR BROKE AND FELL OUT, AND THIS ALLOWED THE SIDE OF THE HORSESHOE CONNECTED TO THE SQUARE SHAFT TO SHIFT. THE PATIENT WAS SUPINE WITH HEAD ON THE HORSESHOE DURING THE PROCEDURE, AFTER INCISION WHEN THE FAILURE OCCURRED. NO PATIENT INJURY AND SURGICAL DELAY HAS BEEN REPORTED.

Additional Manufacturer Narrative

THE MAYFIELD SWIVEL HORSESHOE HEADREST (A1012) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE DHR WAS REVIEWED AND SHOWS NO ABNORMALITIES RELATED TO THE REPORTED FAILURE. FAILURE ANALYSIS - THE INSPECTION SHOWED THAT THE RETURNED UNIT WAS RECEIVED WITHOUT ROLL PINS ALLOWING THE SLIDE BAR TO ROTATE FREELY. ADDITIONALLY, THE UNIT WAS SENT TO QUALITY ENGINEERING (QE) FOR FURTHER INVESTIGATION AND THE FINDINGS OF THE SERVICE TEAM WERE CONFIRMED BY QE. THE UNIT WAS IN WORN CONDITION, AND THE SLIDE BAR WAS MISSING BOTH ROLL PINS AND ABLE TO ROTATE FREELY WHEN IT SHOULD BE FIXED IN PLACE. NO ADDITIONAL DEVICE DEFICIENCIES WERE OBSERVED BY QE. TO RESOLVE THE ISSUES, ALL WORN COMPONENTS WILL BE REPLACED WITH NEW PARTS, AND GENERAL MAINTENANCE AND CLEANING WILL BE PERFORMED. ROOT CAUSE - THE COMPLAINT IS CONFIRMED VIA THE INVESTIGATION. THE UNIT WAS RECEIVED WITHOUT ROLL PINS ALLOWING THE SLIDE BAR TO ROTATE FREELY. THE PROBABLE ROOT CAUSE IS ROUGH OR IMPROPER 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.