NA 251721Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886705012299), received between Sep 28, 2018 and Jul 24, 2024 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (7 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2024Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE TWO (X2) CORDCUTTER DEVICES STITCHES BROKE DURING THE OPERATION. IT WAS NOT REPORTED IF ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY OR PATIENT HARM REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19819861 ↗
• MalfunctionJul 24, 2024Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE TWO (X2) CORDCUTTER DEVICES STITCHES BROKE DURING THE OPERATION. IT WAS NOT REPORTED IF ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY OR PATIENT HARM REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19819799 ↗
• MalfunctionDec 27, 2022Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN SINGAPORE THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE WIRE TIP ON THE 30° SUTURE GRASPER DEVICE BROKE WHILE THE SURGEON WAS TRYING TO EXTRACT THE HANDLE OUT. ACCORDING TO THE REPORT, THE DEVICE WAS USED TO PENETRATE THROUGH LABRAL TISSUE. CHANGED TO ANOTHER ONE BUT THE SAME ISSUE HAPPENED AGAIN. IT WAS REPORTED THAT THE SURGEON TRIED TO SCOPE AROUND TO LOOK FOR THE MISSING 3MM WIRE BUT UNABLE TO LOCATE IT; AND THEREFORE, THE SURGEON ORDERED FOR A POST OP X-RAY TO BE CONDUCTED. IT WAS REPORTED THAT THE PATIENT WAS IN STABLE CONDITION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16055341 ↗
• MalfunctionDec 27, 2022Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN SINGAPORE THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE WIRE TIP ON THE 30° SUTURE GRASPER DEVICE BROKE WHILE THE SURGEON WAS TRYING TO EXTRACT THE HANDLE OUT. ACCORDING TO THE REPORT, THE DEVICE WAS USED TO PENETRATE THROUGH LABRAL TISSUE. CHANGED TO ANOTHER ONE BUT THE SAME ISSUE HAPPENED AGAIN. IT WAS REPORTED THAT THE SURGEON TRIED TO SCOPE AROUND TO LOOK FOR THE MISSING 3MM WIRE BUT UNABLE TO LOCATE IT; AND THEREFORE, THE SURGEON ORDERED FOR A POST OP X-RAY TO BE CONDUCTED. IT WAS REPORTED THAT THE PATIENT WAS IN STABLE CONDITION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16055304 ↗
• MalfunctionMar 15, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6)2022, IT WAS OBSERVED THAT THE NITINOL TIP ON THE IDEAL SUTGRASPER 30 DEG DEVICE BROKE OFF THE TIP OF THE INSERTER WHEN PULLING OUT THE SUTURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 15 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  MAUDE report 13769629 ↗
• MalfunctionApr 24, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THE IDEAL SUTURE GRASPER 30 DEGREE TIP WAS DEFECTIVE. THE CASE WAS COMPLETED WITH ANOTHER LIKE-DEVICE WITH NO PATIENT HARM, BUT A TWO (2) MINUTE DELAY TO OPEN THE NEW DEVICE. THIS REPORT IS FOR AN IDEAL SUTURE GRASPER 30 DEGREE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8545012 ↗
• MalfunctionFeb 28, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED BY THE CUSTOMER VIA PHONE THAT DURING A SHOULDER REPAIR PROCEDURE, BUT PRIOR TO USE ON THE PATIENT, THE CUSTOMER'S IDEAL SUTURE GRASPER 30 DEGREE HAD A LONG HAIR INSIDE THE DEVICE. THE CASE WAS COMPLETED WITH ANOTHER LIKE-DEVICE WITH NO PATIENT HARM OR DELAY. THE CUSTOMER WAS NOT PRESENT AND COULD NOT PROVIDE ANY ADDITIONAL INFORMATION. THE DEVICE IS BEING RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8378764 ↗
• MalfunctionFeb 19, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE THAT DR. XXXX 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 TIP

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8351667 ↗
• MalfunctionOct 10, 2018Break; Break

  IT WAS REPORTED VIA EMAIL FROM A SALES REPRESENTATIVE, WHO RECEIVED A DOCTOR¿S FORUM EMAIL THREAD REPORTING ISSUES WITH IDEAL 30 DEGREE AND 60 DEGREE SUTURE PASSERS. EIGHT DOCTORS WERE ON THE EMAIL THREAD. THE REPORTED PROBLEM WAS THAT THE SUTURE PASSER WAS STRIPPING WHEN PULLING OUT SUTURES IN THE SLIDING, NOT GRASPING, POSITION. THIS COMPLAINT IS BEING OPENED TO DOCUMENT A COMPLAINT EVENT REPORTED FROM ONE OF THE EIGHT DOCTORS. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2018. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7951192 ↗
• MalfunctionOct 9, 2018Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED VIA EMAIL FROM A SALES REP WHO RECEIVED A DOCTOR¿S FORUM EMAIL THREAD REPORTING ISSUES WITH IDEAL 30 DEGREE AND 60 DEGREE SUTURE PASSERS. EIGHT DOCTORS WERE ON THE EMAIL THREAD. THIS COMPLAINT IS BEING OPENED TO DOCUMENT A COMPLAINT EVENT REPORTED FROM ONE OF THE EIGHT DOCTORS. THE REPORTED PROBLEM WAS THAT THE SUTURE PASSER WAS STRIPPING WHEN PULLING OUT SUTURES IN THE SLIDING, NOT GRASPING, POSITION. IT WAS REPORTED THAT THE EVENT OCCURRED DURING AN UNSPECIFIED SURGICAL PROCEDURE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7947113 ↗
• MalfunctionSep 28, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE TWO OF THE CUSTOMER'S IDEAL SUTURE GRASPER 60 DEGREES WIRE TIPS WERE BENT. THE ISSUE WAS DETECTED ONCE THE WIRE HOOK HAD BEEN RELEASED FROM INSIDE THE DEVICE. THE CASE WAS COMPLETED WITH A THIRD LIKE-DEVICE WITH NO PATIENT HARM OR DELAYS. THE SALES REP WAS NOT PRESENT FOR THE CASE AND COULD NOT PROVIDE ANY ADDITIONAL INFORMATION. THE DEVICES ARE RETURNING FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7920988 ↗
• MalfunctionSep 28, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE TWO OF THE CUSTOMER'S IDEAL SUTURE GRASPER 60 DEGREES WIRE TIPS WERE BENT. THE ISSUE WAS DETECTED ONCE THE WIRE HOOK HAD BEEN RELEASED FROM INSIDE THE DEVICE. THE CASE WAS COMPLETED WITH A THIRD LIKE-DEVICE WITH NO PATIENT HARM OR DELAYS. THE SALES REP WAS NOT PRESENT FOR THE CASE AND COULD NOT PROVIDE ANY ADDITIONAL INFORMATION. THE DEVICES ARE RETURNING FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7920983 ↗