ROD SUPPORT CLAMP ASSEMBLY

Description of Event or Problem

THIS IS 2 OF 3 REPORTS FOR PART #443A1060 OF THE RADIOLUCENT SYSTEM, LINKED TO MFG REPORT NUMBERS: 3004608878-2022-00158, 3004608878-2022-00160. A FACILITY REPORTED THAT THE ¿O-RINGS¿ IN THE RADIOLUCENT ROD SUPPORT CLAMP ASSEMBLY (443A1060) HAVE COME OUT OF ITS ORIGINAL PLACE WHICH MAKES IT IMPOSSIBLE TO USE. THE INCIDENT OCCURRED DURING THE FIRST SURGERY ITSELF AS THE WHOLE SYSTEM HAD NEVER BEEN USED. THE MEDICAL STAFF HAD TO CHANGE THE ENTIRE RADIOLUCENT MAYFIELD SYSTEM TO STANDARD MAYFIELD SYSTEM AND USE THE STANDARD BUDDE HALO FOR THE SURGERY. THERE WAS NO PATIENT INJURY SINCE IT WAS NOT USED ON THE PATIENT; HOWEVER, THIS LED TO INCREASED SURGERY TIME OF 90 MINUTES.

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.

Additional Manufacturer Narrative

UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H4, H6, H10. THE RADIOLUCENT BUDDE HALO RETRACTOR SYSTEM (A1096) WAS RETURNED FOR EVALUATION: DEVICE HISTORY RECORD (DHR - THE DHR WAS REVIEWED AND SHOWS NO ABNORMALITIES RELATED TO THE REPORTED FAILURE. FAILURE ANALYSIS - INSPECTION OF THE RETURNED BUDDE HALO SYSTEM CONFIRMS THE REPORTED COMPLAINT. THE O-RINGS HAD COME OUT OF PLACE ON THESE ROD SUPPORT CLAMP ASSEMBLIES. THE O-RINGS WERE EITHER OUT OF PLACE, MISSING, OR BROKEN. AS A RESULT OF THE MISSING O-RINGS, THE KNOBS WERE UNABLE TO STAY IN PLACE WITHIN THE CLAMP ASSEMBLIES. ROOT CAUSE - PROBABLE ROOT CAUSE IS IMPROPER DISASSEMBLY OR MISHANDLING OF THE PARTS. NO FURTHER INVESTIGATION REQUIRED BASED ON THE ACCEPTABILITY OF RISK AND NO ADVERSE TRENDS IDENTIFIED. THIS WILL BE MONITORED AND TRENDED GOING FORWARD.