RHOTON-TYPE BALL DISS 71/2 90D TT

Additional Manufacturer Narrative

THE DEVICE RHOTON-TYPE BALL DISS 71/2 90D TT (277274TI) WAS NOT RETURNED FOR PRODUCT EVALUATION. THE CUSTOMER STATED THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION. EVALUATION AND LOT NUMBER INFORMATION HAVE NOT BEEN PROVIDED; THEREFORE, A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE. THE DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE ISSUE OF BREAKING MAY RESULT FROM WEAR OR ROUGH HANDLING. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

Description of Event or Problem

A FACILITY REPORTED THAT THE RHOTON-TYPE BALL DISS 71/2 90D TT (277274TI) INSTRUMENT BROKE AT A 90-DEGREE ANGLE AT THE TIP AND WAS LEFT IN THE PATIENT. ACCORDING TO ADDITIONAL INFORMATION RECEIVED FROM THE STERILE PROCESSING SUPERVISOR, IT WAS NOTED THAT THE NEUROSURGERY RESIDENT AND THE OPERATING ROOM TEAM WHO WORKED ON THE CASE STATED THAT THE BROKEN PART WAS NOT RECOVERED, AND THE FLUOROSCOPY X-RAY THAT WAS PERFORMED DID NOT DETECT ANY BROKEN PIECES. IT WAS ALSO CONVEYED THAT THE PATIENT WAS UNDER GENERAL ANESTHESIA DURING THE PROCEDURE, AND THE OPERATING ROOM TEAM TRIED TO RETRIEVE THE BROKEN PIECE AFTER "COMMITTING A SIGNIFICANT AMOUNT OF TIME TRYING TO TAKE THE BROKEN PIECE OUT, " BUT IT WAS UNSUCCESSFUL. ACCORDING TO THE NEUROSURGERY RESIDENT, THE PIECE MIGHT HAVE BEEN SUCTIONED OUT WHEN HE WAS DISSECTING TO REMOVE IT, AND THE PATIENT WAS NOTIFIED OF THE INCIDENT." A DIFFERENT INSTRUMENT THAT WAS AVAILABLE WAS USED TO COMPLETE THE SURGERY. POSTOPERATIVELY, THE PATIENT HAD THE SURGERY ON (B)(6) 2025, WAS DISCHARGED ON (B)(6) 2025, AND HAD A RE-ADMISSION DUE TO A COMPLAINT OF NECK PAIN ON (B)(6) 2025 AND DISCHARGED ON (B)(6) 2025.