DRILL, 2.75MM, .066 CANNULATION

Additional Manufacturer Narrative

THE COMPLAINT ALLEGATION IS CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE SHOWING A FRACTURED AR-7000-14 DRILL (2.75 MM, 0.066" CANNULATION), BATCH 022327. ADDITIONALLY, AN X-RAY DEMONSTRATES RETAINED DRILL FRAGMENTS LODGED WITHIN THE PATIENT. BASED ON THE INFORMATION PROVIDED ¿ WHICH MAY INCLUDE THE RETURNED DEVICE (IF AVAILABLE), PHOTOGRAPHS, THE EVENT DESCRIPTION, AND ANY ADDITIONAL FIELD INPUT ¿ ARTHREX HAS DETERMINED THE MOST LIKELY CAUSE OF THE REPORTED ISSUE INVOLVING TWO AR-7000-14 DRILL BITS FRACTURING DURING USE. THE MOST LIKELY CAUSE IS ATTRIBUTED TO USE-RELATED FACTORS, INCLUDING MISALIGNED INSERTION, PRYING OR LEVERAGING THE DRILL, AND EXCESSIVE MECHANICAL STRESS APPLIED DURING DRILLING. THESE CONDITIONS CAN SUBJECT THE DRILL BIT TO UNINTENDED SIDE-LOADING OR TORQUE BEYOND ITS MECHANICAL LIMITS, LEADING TO FRACTURE. PER DFU-0023-EO, REVISION 4 ¿ SECTION I. CAUTION2.: ¿TO AVOID DAMAGING THE INSTRUMENTS, DO NOT IMPACT OR SUBJECT TO BLUNT FORCE ANY INSTRUMENTS THAT ARE DESIGNED TO BE TURNED OR SCREWED IN.¿ 3. ¿DO NOT USE ARTHREX INSTRUMENTS FOR ANY PURPOSE OTHER THAN THEIR INTENDED USE. MANIPULATING SOFT TISSUE OR BONE WITH AN INSTRUMENT NOT INTENDED FOR THAT USE MAY RESULT IN DAMAGE TO THE INSTRUMENT.¿ THESE DFU CAUTIONS SUPPORT THAT IMPROPER FORCE APPLICATION, MISALIGNMENT, OR OFF-AXIS LOADING DURING DRILLING CAN CONTRIBUTE TO INSTRUMENT DAMAGE AND FRACTURE.

Description of Event or Problem

ON 10-JAN-2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA (B)(4) THAT (QTY. 2) OF AN AR-7000-14 DRILL BIT BROKE. IT WAS REMOVED AND THE SURGEON USED A NEW DRILL BIT BUT IT BROKE AGAIN AND WAS REMOVED. THE FRAGMENTS REMAINED INSIDE THE PATIENT. THIS WAS DISCOVERED DURING THE CASE.