APTUS

Additional Manufacturer Narrative

A FOLLOW-UP WILL BE SENT IF NEW INFORMATION IS RETRIEVED.

Description of Event or Problem

THE 2.0 DRILL BIT BROKE OFF INTO LEFT ULNA, ALL PIECES RETRIEVED. NO HARM TO PATIENT. ALL PIECES WERE RETRIEVED.

Additional Manufacturer Narrative

THE INITIALLY PROVIDED ARTICLE NUMBER A-3733 WAS WRONG AND PROVEN BY COMPARISON OF THE DEVICE PICTURES WITH THE DRAWINGS (DRAWING NUMBER 02071.5.7). THE SUSPECTED DEVICE HAS LASER MARKINGS ON THE SPIRAL AND IS THEREFORE A A-3730 TWIST DRILL. INVESTIGATION OF THE DRILL MANUFACTURING RECORD (DHR) WITHOUT THE LOT NUMBER IT'S NOT POSSIBLE. IN OUR INSTRUCTIONS FOR USE, WE RECOMMEND THAT THE USE OF TWIST DRILLS IS LIMITED TO 10 TIMES (CORP-00000406_V2_US_INSTRUCTION_CARE_MAINTENANCE; PAGE 3) AND THAT A MAXIMUM DRILLING SPEED OF 1,000 RPM (APTUS_00000106_USA_REV_W_2022-12-20; WARNINGS) MUST NOT BE EXCEEDED . ACCORDING TO THE INSTRUCTION "CLEANING, DISINFECTION, STERILIZATION, INSPECTION AND MAINTENANCE OF MEDARTIS PRODUCTS" THE FOLLOWING IS RECOMMENDED (CORP-00000406_V2_US_INSTRUCTION_CARE_MAINTENANCE; PAGE 8): 1. AFTER THE INSTRUMENTS ARE CLEANED OR CLEANED AND DISINFECTED, CHECK THEM ALL FOR CORROSION, DAMAGE TO SURFACES, CHIPPING, OTHER ABRASION, CONTAMINANTS AND FUNCTIONALITY. IN CASE IF DAMAGE, THE INSTRUMENTS NEED TO BE REMOVED. 2. CUTTING INSTRUMENTS (E.G. DRILLS) HAVE TO BE CHECKED FOR SHARPNESS AND DAMAGES. WORN OR DAMAGED INSTRUMENTS HAVE TO BE EXCHANGED. IN GENERAL, LOAN SET PRODUCTS SHOULD BE RECOGNIZED AND REPLACED IN ADVANCE AND NOT BE LEFT IN THE OPERATING THEATRE IN THE SET.

Description of Event or Problem

THE 2.0 DRILL BIT BROKE OFF INTO LEFT ULNA, ALL PIECES RETRIEVED. NO HARM TO PATIENT. ALL PIECES WERE RETRIEVED.