TIGHTROPE XP BUTTRESS PLATE IMPLANT SYS

Description of Event or Problem

ON 31-MAR-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-8959TDS SYNDESMOSIS TIGHTROPE XP BUTTRESS PLATE IMPLANT SYSTEM HAD AN ISSUE WITH THE GUIDEWIRE DURING AN OPEN REDUCTION INTERNAL FIXATION ANKLE SYNDESMOTIC STABILIZATION PROCEDURE. THE SUPPLIED GUIDEWIRE WAS USED WITH THE CANNULATED DRILL BIT TO CREATE THE DISTAL TUNNEL; UPON REMOVAL, THE WIRE WAS OBSERVED TO BE THINNED WITH APPARENT METAL SHEARING. THE SURGEON ELECTED NOT TO USE THE WIRE FOR A SECOND TUNNEL AND ATTEMPTED TO USE A FACILITY K-WIRE, WHICH BROKE. A SECOND AR-8959TDS KIT WAS OPENED, AND THE GUIDEWIRE FROM THAT KIT FUNCTIONED AS EXPECTED WITH NO OBSERVED SHEARING. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 02-APR-2026: A FACILITY-SUPPLIED, NON-ARTHREX K-WIRE FRACTURED DURING DRILLING AND WAS FULLY REMOVED INTRAOPERATIVELY. AN UNANTICIPATED MEDIAL INCISION WAS REQUIRED TO FACILITATE REMOVAL DUE TO THE K-WIRE ISSUE. THE CANNULATED DRILL BIT AND GUIDEWIRE SUPPLIED IN THE ARTHREX KIT WERE USED DURING THE PROCEDURE. THE ARTHREX GUIDEWIRE DID NOT COMPLETELY FRACTURE; HOWEVER, IT APPEARED SIGNIFICANTLY COMPROMISED, WITH VISIBLE SHEARING OR THINNING. NO VISIBLE METALLIC DEBRIS OR MATERIAL WAS OBSERVED WITHIN THE SURGICAL SITE. AS A PRECAUTION, THE SITE WAS IRRIGATED WITH SALINE SOLUTION, AND THE PROCEDURE THEN CONTINUED. ALL OTHER COMPONENTS IN THE ARTHREX KIT PERFORMED AS EXPECTED, AND THE ONLY DEVICE CONCERN NOTED WAS RELATED TO THE ARTHREX GUIDEWIRE. THE UNANTICIPATED INCISION AND REMOVAL PROCESS MAY HAVE CONTRIBUTED TO A DELAY OF APPROXIMATELY 10¿20 MINUTES IN SURGICAL TIME. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED.

Additional Manufacturer Narrative

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