TWO HOLE PLATE, SS, STERILE

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 EMAIL THAT AN AR-8958-01S TWO-HOLE PLATE WOULD NOT THREAD THE SCREWS. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS PROVIDED ON 10/02/2025: DURING A SYNDESMOTIC ANKLE DISRUPTION PROCEDURE ON (B)(6) 2025, AN ISSUE AROSE WHILE HAND-TIGHTENING SCREWS INTO THE AR-8958-01S TWO-HOLE PLATE. SPECIFIC PART AND LOT NUMBERS FOR THE SCREWS WERE NOT PROVIDED. THE SCREWS BECAME STRIPPED DURING THE ATTEMPT AND WERE SUBSEQUENTLY REMOVED; HOWEVER, NO COMPONENTS OF THE PLATE OR SCREWS FRACTURED. AS A RESULT, THE PLATE WAS NOT USED, AND A NON-ARTHREX SINGLE LONG SCREW WAS PLACED INSTEAD TO COMPLETE THE CASE. A 20-MINUTE DELAY OCCURRED, BUT NO ADDITIONAL ANESTHESIA WAS REQUIRED. BONE PREPARATION WAS PERFORMED WITH A 2.5 MM DRILL BIT, AND THE BONE QUALITY WAS NOTED AS HARD. NO ALLEGATIONS INVOLVING OTHER SCREWS OR PLATES WERE REPORTED, AND NO ADVERSE EFFECTS OCCURRED DURING OR AFTER THE SURGERY.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE INFORMATION PROVIDED, WHICH MAY INCLUDE THE RETURNED DEVICE (IF AVAILABLE), PHOTOGRAPHS, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL FIELD INPUT, ARTHREX HAS DETERMINED THAT THE MOST LIKELY CAUSE IS ATTRIBUTED TO USE-RELATED FACTORS, INCLUDING EXCESSIVE INSERTION TORQUE, INCOMPLETE THREAD ENGAGEMENT, AND/OR MISALIGNED INSERTION, WHICH MAY HAVE RESULTED IN STRIPPING OF THE SCREW THREADS AND INABILITY TO PROPERLY ENGAGE THE SCREWS WITH THE PLATE.