IDEAL 251007Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886705011681), received between Jan 28, 2019 and Nov 19, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2024Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A LABRUM REPAIR PROCEDURE, IT WAS OBSERVED THAT THE DEVICE BROKE. THERE WAS A DELAY OF TWO MINUTES. IT WAS UNKNOWN IF THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THE EXACT DATE OF THE EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2024. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20723485 ↗
• MalfunctionNov 19, 2024Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A LABRUM REPAIR PROCEDURE, IT WAS OBSERVED THAT THE DEVICE BROKE. THERE WAS A DELAY OF TWO MINUTES. IT WAS UNKNOWN IF THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THE EXACT DATE OF THE EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2024. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20723285 ↗
• MalfunctionNov 18, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE CHIA WIRE WITHIN THE IDEAL SUTRE SHUTLE STRGHT CRESCENT -G BROKE AT THE TIP OF THE KITE. IT WAS REPORTED THAT THE BROKEN CHIA WAS REPLACED WITH ANOTHER CHIA WHICH ALSO BROKE AT THE KITE AREA OF THE CHIA PERCPASSER SUTURE PASSER. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A 10-MINUTE DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 1 OF 2 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20708000 ↗
• MalfunctionApr 2, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6)2024 THE IDEAL SUTRE SHUTLE STRGHT CRESCENT -G DEVICE CHIA WIRE SNAPPED WHEN IT WAS GRABBED INSIDE THE JOINT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A SLIGHT DELAY IN THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19020241 ↗
• MalfunctionOct 20, 2021Difficult to Advance; Difficult to Advance

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT AFTER TAPPING THE ANCHOR AND PULLING OUT THE GUIDE ON THE IDEAL SUTRE SHUTLE STRGHT CRESCENT DEVICE, THE ANCHOR SUTURE CAME OUT WITH THE GUIDE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 12667047 ↗
• MalfunctionJan 28, 2019Break; Break

  THIS IS REPORT 2 OF 3 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A LABRAL REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE NITINOL WIRE BROKE WHEN PULLING THE IDEAL SUTURE SHUTTLE 45 DEGREES LEFT TAPE THROUGH. IT WAS REPORTED THAT THIS HAPPENED ON THREE IDEAL SUTURE SHUTTLE 45 DEGREES LEFT DEVICES. ACCORDING TO THE REPORTER, THE SURGEON WAS PULLING GENTLY BUT THE DEVICES STILL BROKE. THE SURGEON OPENED THREE EXTRA SHUTTLES TO COMPLETE THE PROCEDURE WITH A 15 MINUTE DELAY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO 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 Consequences Or Impact To Patient

  MAUDE report 8282232 ↗