DRILL BIT Ø2 QC L140 CALIBRATION 60

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT ORIF SURGERY FOR OLECRANON FRACTURE. IN THE SURGERY, FOUR PROXIMAL SCREWS WERE INSERTED, AND DRILLING WAS PERFORMED TO INSERT ANOTHER SCREW INTO THE SECOND HOLE FROM THE PROXIMAL END. DURING DRILLING, THE DRILL BIT INTERFERED WITH THE ALREADY INSERTED SCREWS, AND APPROXIMATELY 5 CM OF THE DRILL BIT TIP BROKE OFF. THE SURGEON CONSIDERED REMOVING THE DRILL BIT, BUT BECAUSE IT REMAINED IN A DEEP POSITION, IT WOULD HAVE REQUIRED REMOVING ALL THE SCREWS THAT HAD BEEN INSERTED SO FAR AND RETRIEVING IT FROM THE FRACTURE SITE, SO THE REMOVAL OF THE DRILL BIT WAS ABANDONED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.