IDEAL 251003Recalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 10886705011643), received between Feb 12, 2018 and Aug 5, 2026 — classified as 1 injury, 86 malfunctions.

The most frequently reported specific device problem is “Break” (42 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 87 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2026Unintended Movement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50138754 ↗
• MalfunctionAug 3, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50122226 ↗
• MalfunctionJul 9, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25766482 ↗
• MalfunctionJun 9, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THE IDEAL SUTURE SHUTTLE 45 DEGREES LEFT DEVICE WHEN THE SURGEON TRIED TO THREAD THE SUTURE THROUGH THE SUBSCAPULARIS TENDON, THE WIRE TIP BECAME DIFFICULT TO ACCESS. FURTHERMORE, WHEN THE SURGEON TRIED TO PASS THE SUTURE THROUGH THE LOOP, THE WIRE TWISTED, PREVENTING THE SECOND STITCH FROM BEING COMPLETED.. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO FRAGMENTS LEFT WITHIN THE PATIENT. 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 25448487 ↗
• MalfunctionJun 9, 2026Break

  IT WAS REPORTED THAT DURING ROTATOR CUFF REPAIR SURGERY, THE IDEAL SUTURE SHUTTLE RING BROKE OFF. ALL THE BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25441457 ↗
• MalfunctionJun 1, 2026Device-Device Incompatibility

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE CHIA WIRE ON THE IDEAL SUTURE SHUTTLE 45 DEGREES LEFT DEVICE COULD NOT SLIDE. 4.75 HEALIX ADVANCE KNTLSS BR DEVICE WAS USED TO CONTINUE THE SURGERY, BUT THE ANCHOR BROKE OFF. ALL THE BROKEN PARTS WERE REMOVED. THERE WERE NO DELAYS IN 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 25354393 ↗
• MalfunctionMay 28, 2026Unintended Movement

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, WHILE USING THE IDEAL SUTURE SHUTTLE 45 DEGREES LEFT DEVICE, IT WAS OBSERVED THAT THE SUTURE SHUTTLE RING WAS LOOSE. IT WAS REPORTED THAT 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 25323148 ↗
• MalfunctionJan 8, 2026Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, THE TWO (X2) 4.5 HEALIX ADVANCE BR W/OCORD DEVICES WERE BEING USED WHEN THE ANCHOR WAS BROKEN OFF, REMOVED ALL THE BROKEN PARTS. CHANGED ANOTHER ANCHOR TO CONTINUE THE SURGERY, THE METAL SHAFT OF DEVICE WAS BROKEN. ANOTHER DEVICE AND ANOTHER ANCHOR WERE USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 2 OF 2 FOR THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24006135 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE NEEDLE TIP OF THE IDEAL SUTURE SHUTTLE 45 DEGREES LEFT 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 23982221 ↗
• MalfunctionDec 10, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, THE IDEAL SUTURE SHUTTLE 45 DEGREES LEFT DEVICE PULLEY OF THE DEVICE WAS BLOCKED AND CANNOT SLIDE THE CABLE. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY, SO THE ASPIRATOR WAS NO PROBLEM. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23768143 ↗
• MalfunctionNov 20, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, IT WAS OBSERVED THAT IDEAL SUTURE SHUTTLE 45 DEGREES LEFT DEVICE CHIA WIRE WOULD NOT ADVANCE AND IT WAS STUCK INSIDE THE SHUTTLE. 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 23603409 ↗
• MalfunctionNov 13, 2025Break; Device Damaged Prior to Receipt by User; Break; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE GUIDEWIRE PUT OF THE HANDLE AND THE LOOP OF THE IDEAL SUTURE SHUTTLE 45 DEGREES LEFT DEVICE WAS BROKEN. IT WAS NOTED IN THE SERVICE ORDER THAT THE SHUTTLE RING WAS FOUND TO BE LOOSE IN THE PACKAGE. 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 23547544 ↗
• MalfunctionNov 6, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE SHUTTLE RING OF THE IDEAL SUTURE SHUTTLE 45 DEGREES LEFT DEVICE WAS LOOSE. 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 23491015 ↗
• MalfunctionNov 5, 2025Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT DURING MENISCAL REPAIR PROCEDURE, UPON OPENING THE IDEAL SUTURE SHUTTLE 45 DEGREES LEFT DEVICE AND PUTTING IT ON STERILE FIELD, IT WAS NOTICED THAT THE PACKAGING WAS OPEN FROM THE BOX. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. IT WAS REPORTED THAT THERE WAS NO PATIENT HARM. THERE WAS AN UNSPECIFIED AMOUNT OF SURGICAL DELAY. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23477655 ↗
• MalfunctionOct 23, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE IDEAL SUTURE SHUTTLE 45 DEGREES LEFT DEVICE RING WAS BROKEN OFF. ALL BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. 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 23367500 ↗
• MalfunctionSep 12, 2025Break; Break

  IT WAS REPORTED THAT DURING AN AUDITORY BRAINSTEM RESPONSE (ABR) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE IDEAL SUTURE SHUTTLE 45 DEGREES LEFT DEVICE WIRE BROKE AND IT BECAME UNUSABLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. IT WAS CONFIRMED THAT THE BROKEN WIRE WAS NOT LEFT INSIDE THE BODY. 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 23038508 ↗
• MalfunctionMay 7, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE THE IDEAL SUTURE SHUTTLE 45 DEGREES LEFT DEVICE KITE WAS LOOSE AND THE DEVICE COULD NOT BE USED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21980473 ↗
• MalfunctionJan 23, 2025Material Deformation; Material Deformation

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE FOR A SHOULDER ROTATOR CUFF TEAR, IT WAS DISCOVERED THAT THE IDEAL SUTURE SHUTTLE 90 DEGREE DEVICE AND IDEAL SUTURE SHUTTLE 45 DEGREE LEFT DEVICE WERE BOTH ATTEMPTED FOR PENETRATION OF THE ROTATOR CUFF. HOWEVER, BOTH DEVICES BECAME SIGNIFICANTLY BENT ON THE FIRST ATTEMPT, PROMPTING THE PROCEDURE TO BE HALTED. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT REPORTED. 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 21216975 ↗
• MalfunctionSep 13, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON AN UNKNOWN DATE THE IDEAL SUTURE SHUTTLE 45 DEGREES LEFT DEVICE HOOK WAS BENT. 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 20210197 ↗
• MalfunctionSep 5, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT DURING AN ARTHROSCOPIC SHOULDER LABIAPLASTY SURGICAL PROCEDURE ON THE SHOULDER JOINT TO TREAT A DISLOCATED SHOULDER ON (B)(6) 2024 THE IDEAL SUTURE SHUTTLE 45 DEGREES LEFT DEVICE DID NOT COME OUT PROPERLY AND COULD NOT BE USED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A THIRTY MINUTE DELAY IN THE PROCEDURE WAS REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20151829 ↗
• MalfunctionAug 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024 THE IDEAL SUTURE SHUTTLE 45 DEGREES LEFT DEVICE WIRE OF THE PRODUCT IN QUESTION DID NOT COME OUT. 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 20029856 ↗
• MalfunctionJul 16, 2024Break; Break

  IT WAS REPORTED FROM JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE, IT WAS OBSERVED THAT THE IDEAL SUTURE SHUTTLE 45 DEGREES LEFT DEVICE BROKE. THERE WERE NO BROKEN PIECES LEFT IN THE PATIENT. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19751594 ↗
• MalfunctionJul 11, 2024Material Deformation; Material Deformation

  IT WAS REPORTED FROM CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE SURGEON FOUND THE TIP OF THE IDEAL SUTURE SHUTTLE 45 DEGREES LEFT DEVICE TO BE EASILY BENDABLE. 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 WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19719460 ↗
• MalfunctionApr 23, 2024Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED BY THE SALES REP THAT DURING A LABRAL REPAIR PROCEDURE THE IDEAL SUTURE SHUTTLE 45 DEGREES LEFT AND THE IDEAL SHUTTLE 45 DEGREES RIGHT DEVICES WERE BEING USED WHEN THE CHIA PORTION DIDN'T SLIDE PROPERLY IN THE BODY OF THE INSTRUMENT GETTING CAUGHT AND ONE OF THE CHIA WAS LOOSE WHEN OPENED AND FELL ON THE FLOOR BEFORE USING. 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. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19164344 ↗
• MalfunctionMar 25, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024 THE IDEAL SUTURE SHUTTLE 45 DEGREES LEFT DEVICE SUTURE SHUTTLE RING WAS LOOSE. 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 18969874 ↗