ACU-SINCH KNTLS MINI SYS W/INSRTR 2.3

Additional Manufacturer Narrative

TO DATE, THE DEVICE HAS NOT RETURNED FOR EVALUATION, THE ROOT CAUSE COULD NOT BE ESTABLISHED. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A FOLLOW UP REPORT IF MORE INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT CMC SUSPENSION PLASTY SURGERY USING ACU-SINCH CMC ON (B)(6) 2025. PATIENT WAS SEEN ON (B)(6) 2025 FOR X-RAYS AND IMPLANT CAME LOOSE. THE SURGEON'S PA COMMENTED ON THE PATIENT SAYING THEY WERE "OPENING PILL BOTTLES WITH THE HAND". THE REVISION WAS PERFORMED (B)(6) 2025. THE BUTTON WAS INTACT AND WAS CUT IN ORDER TO REMOVE. THE SURGEON OPTED TO DO A LIGAMENT RECONSTRUCTION FOR PRIMARY REVISION. THE REPORTER STATED, "WE'RE UNFORTUNATELY STILL UNSURE OF THE EXACT CAUSE OF THE FAILURE. THE SURGEON'S PA DID NOTE THAT THE PATIENT WAS "OPENING PILL BOTTLES" WHICH COULD HAVE LEAD TO THE BUTTON FLIPPING BACK AND PASSING THROUGH THE 2ND MET TUNNEL POSSIBLY. THE REVISION SURGERY WAS PERFORMED WITHOUT ANY COMPLICATIONS.