2.5 X 30MM PIP DART, PEEK, 10 DEGREE

Additional Manufacturer Narrative

INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

Description of Event or Problem

ON 09/09/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (2) AR-4154PS-3010 PIP DARTS BROKE. THIS OCCURRED DURING A HAMMERTOES PROCEDURE ON (B)(6) 2024 EACH TIME THE JOINT WAS PREPPED AND ATTEMPTED TO INSERT THE ANCHOR IT BROKE OFF, THIS OCCURRED WITH BOTH DEVICES. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THE PATIENT HAD A DECENT BONE QUALITY, THAT WAS PREPPED USING THE DRILL IN THE KIT. THE CASE PROCEEDED USING DIFFERENT SCREWS. THE CASE TOOK LONGER, BUT THE REPRESENTATIVE WAS UNSURE IF ADDITIONAL ANESTHESIA WAS ADMINISTERED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: G3, H3, H6 BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO IMPROPER BONE PREP; MISALIGNED INSERTION; PRYING/LEVERAGING THE DEVICE DURING INSERTION.