HAND DRILL - STERILE

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 REPORT IS 1 OF 2 FOR THE SECOND CASE BASED ON FRENCH AUTHORITY REPORT (ANSM) WHICH INDICATES THAT 3 DIFFERENT DOCTORS EXPERIENCED THIS SAME ISSUE IN INTENSIVE CARE. THIS REPORT IS LINKED TO MFG REPORT NUMBER 3013886523-2024-00068: A FACILITY REPORTED THAT THE DRILL BITS FROM LICOX KIT IP2P ARE NOT ADAPTED TO CRANIAL HAND DRILL INS030. NO PATIENT INJURY OR INCREASED SURGERY TIME HAS BEEN REPORTED.

Description of Event or Problem

N/A.

Additional Manufacturer Narrative

THE HAND DRILL (INS030) WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE "ACTUAL" DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. FAILURE ANALYSIS - THE INS030 DRILL IS AUTHORIZED FOR USE WITH THE 4 INTEGRA BRAND DRILL BITS LISTED IN THE IFU (INSTRUCTIONS FOR USE). THE UNAUTHORIZED IP2 DRILL BIT IS NOT AMONG THOSE 4. ALTHOUGH THE EXACT HAND DRILL AND DRILL BIT USED IN THE PROCEDURE THAT LED TO THIS COMPLAINT WERE NOT RECEIVED BY THIS SITE, A DRILL BIT OF SIMILAR ADVERTISED DIMENSIONS TO THE IP2 DRILL BIT WAS PAIRED WITH ONE OF THE INS030 HAND DRILLS FOR EXAMINATION. IT WAS CONFIRMED THAT THESE ARE NOT COMPATIBLE AND WILL NOT REMAIN STEADY OR SAFE FOR USE ON A PATIENT. THEREFORE, THE DRILL CHUCK IS NOT COMPATIBLE WITH THE BIT USED BY THE CUSTOMER. ROOT CAUSE - THE ROOT CAUSE IDENTIFIED IS "OFF-LABEL CUSTOMER USE." NO ADVERSE TREND HAS BEEN IDENTIFIED; AS SUCH, NO CORRECTIVE ACTION IS BEING INITIATED AT THIS TIME. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.