IDEAL 251006Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886705011674), received between Sep 24, 2018 and Jan 16, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2025Material Deformation; Material Deformation

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WAS BENT INSITU. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21169982 ↗
• MalfunctionJan 16, 2025Material Deformation; Material Deformation

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WAS BENT INSITU. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21169980 ↗
• MalfunctionJan 27, 2020Break; Break

  IT WAS REPORTED BY THE AFFILIATE THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR THE WIRE OF THE IDEAL SUTURE SHUTTLE STRAIGHT HOOK -G BROKE DURING SUTURE RELAY FOR THE SUTURE. THERE WAS NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9633291 ↗
• MalfunctionSep 24, 2018Break; Break

  THIS IS REPORT 1 OF 3 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING SHOULDER STABILISATION SURGICAL PROCEDURE, IT WAS OBSERVED THAT THERE WERE FAULTS WITH THE IDEAL SUTURE SHUTTLES. THE KITE OF THE CHIA WIRE BROKE ON FIRST USE IN EVERY SINGLE IDEAL SHUTTLE. THE SURGEON WAS USING THEM UNDER NORMAL CONDITIONS WITHOUT EXCESSIVE FORCE BUT THEY BROKE. THE SALES REP BELIEVES THE CHIA WIRE NEEDS TO BE FAR STRONGER IN ORDER TO PERFORM AS IT SHOULD. IT WAS REPORTED THAT THE DEVICES HAVE BEEN DISCARDED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7901842 ↗