SUPPORT BRACKET ASSM

Additional Manufacturer Narrative

THE BUDDE HALO BRACKET (438B1010) WAS RETURNED FOR EVALUATION: FAILURE ANALYSIS - THE EVALUATION SHOWED THAT THE LOCKING RING WAS SCREWED INTO THE CLAMP AT AN ANGLE AND WAS STUCK AND UNABLE TO TURN. ADDITIONALLY, THE LOCKING RING WAS BROKEN AND STUCK IN THE THREAD. THIS IS CONSIDERED INCORRECT USE. TO RESOLVE THE ISSUE, THE LOCKING RING WAS REPLACED, THE UNIT WAS MARKED WITH THE INSTANCE NUMBER AND A SUCCESSFUL FUNCTION TEST WAS PERFORMED. ROOT CAUSE - THE COMPLAINT IS CONFIRMED VIA INSPECTION OF THE UNIT. THE LOCKING RING WAS BROKEN AND STUCK IN THE THREAD DUE TO IMPROPER ASSEMBLY. 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.

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

THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3004608878-2024-00085: A DISTRIBUTOR REPORTED THAT THE END USER IS FACING AN ISSUE WITH THE BUDDE HALO BRACKET (438B1010) BEING BROKEN AND DEFECTIVE, WHICH ARE BRAND NEW UNITS RECENTLY SUPPLIED AS COMPLETE SET ¿ PART OF A1040 BUDDE HALO RETRACTOR. THE SURGEON NOTICED THAT THESE RECENTLY SUPPLIED DEFECTIVE BRACKETS ARE MATT FINISH PRODUCTS WITH POOR QUALITY WHEN COMPARING SAME BRAND PRODUCTS SUPPLIED IN PREVIOUS YEARS. THIS 2ND PIECE 438B1010 BUDDE HALO SUPPORT BRACKET WAS TIGHT & BENT. ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: WHEN THE ISSUE WAS DISCOVERED (BEFORE, DURING AFTER SURGERY)? BEFORE THE SURGERY. IF IT WAS BEFORE OR DURING SURGERY, HOW DID THEY FINISH THE SURGERY? USED ANOTHER INTEGRA BUDDE HALO SYSTEM . IF IT WAS BEFORE OR DURING SURGERY, WAS THE SURGERY TIME INCREASE OF MORE THAN 30 MINUTES? YES. DID THE ISSUE HAVE CONSEQUENCE FOR THE PATIENT IF YES WHICH ONE? NO.