COMPRESSION BALL

Description of Event or Problem

THIS IS 3 OF 3 REPORTS FOR PART #443A1067, LINKED TO MFG REPORT NUMBERS: 3004608878-2022-00158, 3004608878-2022-00159. A FACILITY REPORTED THAT THERE WAS A CRACK IN THE AREA WHERE THE COMPRESS BALL (443A1067) IS PLACED IN THE RADIOLUCENT HALO RING SYSTEM. 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.

Description of Event or Problem

N/A

Additional Manufacturer Narrative

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. THERE WAS A SMALL CRACK IN THE THREADS WHERE THE COMPRESSION BALL IS PLACED. ROOT CAUSE - PROBABLE ROOT CAUSE IS PHYSICAL DAMAGE FROM ROUGH HANDLING OF THE UNIT. NO FURTHER INVESTIGATION REQUIRED BASED ON THE ACCEPTABILITY OF RISK AND NO ADVERSE TRENDS IDENTIFIED. THIS WILL BE MONITORED AND TRENDED GOING FORWARD.

Additional Manufacturer Narrative

CORRECTED FIELDS: H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION).

Description of Event or Problem

N/A