BUDDE HALO RETRACTOR SYSTEM

Additional Manufacturer Narrative

THE DEVICE WAS NOT YET RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ELECTIVE CRANIOTOMY AND REMOVAL OF A TUBERCULUM SELLAE MENINGIOMA . BEFORE STARTING THE CRANIOTOMY, THE CUSTOMER CHECKED THE BUDDE HALO RETRACTOR SYSTEM AND FOUND THAT SOME OF THE COMPONENTS WERE MISSING AND OTHERS WERE FAULTY. SPECIFICALLY, ONE OF THE SNAKE RETRACTORS WAS MISSING AND THE OTHER TWO COULD NOT HOLD THEIR STIFFNESS. ALSO ONE OF THE RODS COULD NOT BE ENGAGED INTO THEIR FEMALE COUNTERPART DUE TO WEAR AND TEAR IN THE LATTER. ON INSPECTION AND PROVISIONAL ASSEMBLING, THERE DID NOT SEEM TO BE ANY GROSS FAULTS. DURING THE INTER - HEMISPHERIC FISSURE DISSECTION, THE CUSTOMER HAD TO CHANGE THE POSITION OF THE RETRACTOR BLADES A NUMBER OF TIMES DUE TO ONE OF THE NEW SET SNAKE RETRACTORS NOT HOLDING ITS STIFFNESS EVEN AFTER MAXIMUM TIGHTENING. DURING ONE OF THESE MANEUVERS, THE RETRACTOR BLADE MOVED WITH A SUDDEN JERK AND AVULSED A SMALL BRANCH AT THE A2-3 SEGMENT OF THE LEFT ANTERIOR CEREBRAL ARTERY. THE BUDDE HALO FRAME WAS NOT STABLE DURING USE.

Description of Event or Problem

N/A.

Additional Manufacturer Narrative

THE DEVICE WAS NOT RELEASED FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS LOT OR SERIAL NUMBER WAS NOT PROVIDED. SAMPLING PLAN REVIEWED AND WAS ACCEPTABLE. DEVICE WAS 100% TESTED PRIOR TO FINAL ACCEPT. "MARKETING INSTALL BASE" SHOWED THERE WERE (9) BUDDE HALO A1040 BRAIN RETRACTOR SYSTEMS PURCHASED BY THE (B)(6). EACH SET INCLUDES (3) 438A1011 RETRACTOR ARM ASSEMBLIES. RATINGEN REPAIR DEPOT COULD NOT FIND RECORDS OF SERVICE AND REPAIR OR PREVENTATIVE MAINTENANCE. THE COMPLAINT WAS NOT CONFIRMED. FAILURE ANALYSIS TO IDENTIFY ROOT CAUSE TO THE END USER'S EXPERIENCE COULD NOT BE DETERMINED.