K-LESS T-ROPE W/DRV, SYN REPR, TI

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, G3, H3, H6. THE COMPLAINT ALLEGATION IS CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE SHOWING DAMAGE TO AN AR-8925T, BATCH 15532791. THE IMAGE SHOWS A FIBERTAK IMPLANT SYSTEM WITH THE HANDLE, INSERTER SHAFT, AND SUTURE LIMBS VISIBLE. ONE SUTURE LIMB APPEARS FRAYED AT THE DISTAL TIP, SUGGESTING TENSIONING OR PULL-THROUGH OCCURRED. 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 THE MOST LIKELY CAUSE. THE MOST LIKELY CAUSE IS ATTRIBUTED TO USER-RELATED FACTORS SUCH AS OFF-AXIS INSERTION AND INCOMPLETE DRIVER SEATING.

Description of Event or Problem

IT WAS REPORTED THAT DURING A LIGAMENT REPAIR SURGERY, WHEN USING THE DEVICE, IT BECAME ¿JAMMED¿ AND WAS DIFFICULT TO OPERATE. THE BUTTON AT THE FRONT MUST HAVE COME LOOSE IN THE CHANNEL BEFORE IT WAS INSERTED. NEVERTHELESS, ALL THE SUTURES WERE STILL ATTACHED TO THE APPLICATOR. THIS CAUSED THE BUTTON ITSELF TO BECOME ¿JAMMED¿ IN THE CHANNEL. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

Additional Manufacturer Narrative

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