IDEAL 251005Recalls & reported problems

Summary

The FDA's MAUDE database contains 99 adverse event reports that list this exact device (DI 10886705011667), received between Aug 7, 2018 and Sep 21, 2026 — classified as 99 malfunctions.

The most frequently reported specific device problem is “Break” (48 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 25 most recent of 99 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Break

  It was reported that during an unknown procedure, it was discovered that the suture shuttle ring on the IDEAL SUTURE SHUTTLE 90 DEGREES device broke off. It was not reported if there were any delays to the surgical procedure. It was reported that a spare device was used to complete the surgery. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50845270 ↗
• MalfunctionSep 15, 2026Break; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50776895 ↗
• MalfunctionSep 14, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50757261 ↗
• MalfunctionJun 12, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THE IDEAL SUTURE SHUTTLE 90 DEGREES DEVICE THE TIP OF THE WIRE LOOP PART BROKE. THERE WAS NOTHING REMAINING IN THE BODY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25488177 ↗
• MalfunctionMay 27, 2026Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE, WHILE USING A IDEAL SUTURE SHUTTLE 90 DEGREES DEVICE IT WAS OBSERVED THAT THE TIP WAS BROKEN OFF. IT WAS REPORTED THAT ANOTHER LIKE DEVICE WAS USED TO CONTINUE THE PROCEDURE. IT WAS REPORTED THAT IN THE SAME PROCEDURE, WHEN USING A VAPR PREMIERE50 ELECTRODE DEVICE AFTER CONNECTING TO THE GENERATOR, IT WAS OBSERVED THAT DEVICE DID NOT FUNCTION AT ALL, AND THE SCREEN DID NOT SHOW ANY ALERT CODE. IT WAS REPORTED THAT ANOTHER LIKE DEVICE WAS USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25305003 ↗
• MalfunctionMay 26, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY, THE IDEAL DEVICE WIRE COULD NOT BE PUSHED OUT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25280828 ↗
• MalfunctionMay 5, 2026Crack

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR, THE IDEAL SUTURE WAS INSERTED THROUGH THE ROTATOR CUFF AND REMOVED WITH A RETRIEVER, BUT THE WIRE TIP FRAYED. A NEW ONE WAS INSERTED AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25080294 ↗
• MalfunctionApr 14, 2026Break

  IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGICAL PROCEDURE FOR ANTERIOR CRUCIATE LIGAMENT (ACL) TIBIAL AVULSION FRACTURE, WHEN USING THE IDEAL SUTURE SHUTTLE 90 DEGREES DEVICE TO SUTURE THE ACL, THE TIP BROKE, MAKING IT IMPOSSIBLE TO SUTURE. AFTER THE BREAK, ANOTHER DEVICE WAS USED TO SUTURE, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. IT WAS REPORTED THAT NO INTERNAL REMNANTS OF THE BROKEN TISSUE REMAINED. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24871496 ↗
• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THAT THE IDEAL SUTURE SHUTTLE 90 DEGREES DEVICE WAS BROKEN. CHANGED ANOTHER TWO TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN.. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24819568 ↗
• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THAT THE IDEAL SUTURE SHUTTLE 90 DEGREES DEVICE WAS BROKEN. CHANGED ANOTHER TWO TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN.. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24819563 ↗
• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THAT THE IDEAL SUTURE SHUTTLE 90 DEGREES DEVICE WAS BROKEN. CHANGED ANOTHER TWO TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24819509 ↗
• MalfunctionMar 24, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) PROCEDURE, THE TIP OF THE IDEAL SUTURE SHUTTLE 90 DEGREES DEVICE WAS INSERTED THROUGH THE SUPRASPINATUS MUSCLE AND THE SHUTTLE WIRE TIP BROKE WHILE RELAYING A HEALIX TAPE. THE SHUTTLE WAS NOT RETAINED IN THE PATIENT; A NEW SUTURE SHUTTLE WAS OPENED AND THE SURGERY WAS COMPLETED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681705 ↗
• MalfunctionMar 11, 2026Material Deformation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC LABRAL ARTHROPLASTY FOR SHOULDER LABRUM TEAR PROCEDURE THAT THE IDEAL SUTURE SHUTTLE 90 DEGREES DEVICE BENT WHERE IT NARROWED FROM THE SHAFT WIDTH, MAKING IT UNUSABLE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS WITHIN 30MINS OF SURGICAL DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24576169 ↗
• MalfunctionJan 26, 2026Material Deformation

  THIS IS REPORT 2 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE THE IDEAL SUTURE SHUTTLE 90 DEGREES DEVICE, THE NEEDLE WAS BROKEN OFF AND THE NEEDLE WAS DEFORMED. THE USER CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY AND THE NEEDLE WAS DEFORMED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24178563 ↗
• MalfunctionJan 26, 2026Break

  THIS IS REPORT 1 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE THE IDEAL SUTURE SHUTTLE 90 DEGREES DEVICE, THE NEEDLE WAS BROKEN OFF AND THE NEEDLE WAS DEFORMED. THE USER CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY AND THE NEEDLE WAS DEFORMED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24178547 ↗
• MalfunctionJan 23, 2026Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, THE NEEDLE TIP OF THE IDEAL SUTURE SHUTTLE 90 DEGREES WAS BROKEN OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24167143 ↗
• MalfunctionJan 23, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER STABILIZATION SURGICAL PROCEDURE IT WAS OBSERVED THAT THE COIL AT THE FRONT END OF IDEAL SUTURE SHUTTLE 90 DEGREES DEVICE BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24162016 ↗
• MalfunctionJan 21, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE IDEAL SUTURE SHUTTLE 90 DEGREES DEVICE KITE WAS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24134441 ↗
• MalfunctionJan 21, 2026Material Deformation

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE IDEAL SUTURE SHUTTLE 90 DEGREES NEEDLE WAS DEFORMED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24130039 ↗
• MalfunctionJan 12, 2026Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, THE IDEAL SUTURE SHUTTLE 90 DEGREES DEVICE NEEDLE TIP OF DEVICE TIP WAS BROKEN OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24035484 ↗
• MalfunctionJan 7, 2026Material Deformation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE, THE IDEAL SUTURE SHUTTLE 90 DEGREES DEVICE WAS BEING USED WHEN THE SURGEON INSERTED THE SUTURE SHUTTLE INTO THE ROTATOR CUFF AND USED IT AS NORMAL, BUT THE TIP OF THE SUTURE SHUTTLE BENT AFTER THE FIRST USE. THE SURGEON TRIED TO MANUALLY STRAIGHTEN THE SUTURE SHUTTLE, BUT IT SEEMED TO HAVE BECOME SOFT, SO HE DISCARDED IT TO PREVENT IT FROM BREAKING. THE NEW IDENTICAL PRODUCT WAS OPENED AND USED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23988815 ↗
• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE IDEAL SUTURE SHUTTLE 90 DEGREES DEVICE WAS BROKEN. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23854429 ↗
• MalfunctionNov 18, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT UPON INSPECTION OF THE PRODUCTS PRIOR TO OPENING THE PACKAGING, IT WAS FOUND THAT THE PRODUCT INFORMATION ON THE FRONT OF THE OUTER PACKAGING WAS CORRECT, THE CODE IS IDEAL SUTURE SHUTTLE 90 DEGREES UP, HOWEVER, THE PRODUCT INFORMATION ON THE BACK OF THE OUTER PACKAGING WAS INCORRECT, THE CODE WAS IDEAL SUTURE SHUTTLE 45 DEGREES LEFT. IT WAS FURTHER OBSERVED THAT THE LABEL AT THE SEAL WAS ALSO INCORRECT. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23587118 ↗
• MalfunctionNov 13, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON THE SHOULD FOR A ROTATOR CUFF TEAR, THE IDEAL SUTURE SHUTTLE 90 DEGREES DEVICE AFTER THE PRODUCT IN QUESTION WAS OPENED AND TWO USES, IT BROKE AT THE JOINT BETWEEN THE TIP AND THE MAIN SHAFT, MAKING IT UNUSABLE. THE NEW PRODUCT WAS OPENED, USED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS A 30 MINUTE SURGICAL DELAY, NO PIECES LEFT IN THE BODY AND NO HARM TO THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543207 ↗
• MalfunctionNov 5, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, IT WAS OBSERVED THAT THE IDEAL SUTURE SHUTTLE 90 DEGREES DEVICE WAS DEFORMED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23477348 ↗