NA 251720Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705012282), received between Feb 19, 2019 and Nov 26, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED DURING AN UNSPECIFIED PROCEDURE, THE TIP OF THE IDEAL SUTGRASPER 15 DEG *EA DEVICE STOPPED OPENING AFTER ONLY A COUPLE OF PASSES. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20777142 ↗
• MalfunctionFeb 19, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE AFFILIATE THAT DR. XXXXX WAS DOING A REMPLISSAGE PROCEDURE USING THE HEALIX BR 3.4 MM ANCHOR AND PASSING SUTURE RETROGRADE WITH THE IDEAL SUTURE GRASPERS. THE FIRST HEALIX BR 3.4MM ANCHOR HE WENT TO IMPLANT AND THE TIP OF THE ANCHOR SNAPPED JUST TRYING TO PUSH THE ANCHOR THROUGH THE TISSUE TO GET TO THE BONE HOLE. I SUGGESTED WE OPEN AND USE THE PERCANNULA SYSTEM TO MAKE THIS PROCEDURE AND IMPLANTING THE ANCHORS EASIER AND HE AGREED SO WE OPENED THE PERCANNULA AND IMPLANTED A HEALIX BR 3.4MM ANCHOR WITH NO ISSUES. WE THEN OPENED A 30 DEGREE IDEAL SUTURE GRASPER AND WHEN WE HAD THE SUTURE HOOKED IN THE RETRIEVAL CLIP AND WENT TO PULL IT THROUGH THE TISSUE THE CLIP DID NOT HANG ON TO THE STITCH AND STRAIGHTENED OUT MAKING THE TOOL UNUSABLE. WE OPENED A 15 DEGREE IDEAL SUTURE GRASPER TO TRY AS HE THOUGHT THAT ANGLE MIGHT BE BETTER ANYWAY AND THE SAME THING HAPPENED. HE REALIZES THE CLIPS ON THESE ARE FRAGILE, BUT FOR THAT TO HAPPEN ON ONE PASS EACH WAS NOT ACCEPTABLE TO HIM. WE OPENED ONE MORE 15 DEGREE IDEAL SUTURE GRASPER, I GOT HIM TO SLOW DOWN AND LISTEN TO MY ADVICE AND ONCE HE HAD THE SUTURE IN THE GRASPER TO PUT IT IN ¿SLIDE¿ MODE AND GENTLY TOGGLE THE TI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8351754 ↗