LO-PRO SCRW, CANN, BLUNT TIP, 4 X 36 MM

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 (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-5051-36 LOW PROFILE SCREW WAS BEING ADVANCED BY HAND AND THE SCREW HEAD BROKE OFF OF THE SHAFT. THIS WAS DISCOVERED DURING A CASE. AN ADDITIONAL HOUR WAS ADDED TO THE CASE. THE FACILITY NEEDED A STERILE TRANSFER FOR A SCREW REMOVAL SET.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: G3, H3, H6. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. 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 CONCLUDED THAT THE MOST LIKELY CAUSE OF THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR DUE TO IMPROPER BONE PREPARATION, MISALIGNMENT INSERTION, AND/OR PRYING/LEVERAGING OF THE DEVICE. ADDITIONALLY, THE USE OF A CANNULATED DRIVER HANDLE IS ALWAYS RECOMMENDED. THE COMPLAINT ALLEGATION WAS CONFIRMED BASED ON THE CUSTOMER'S ATTACHED PICTURE, WHERE A SCREW WAS DISPLAYED BROKEN OFF.