IDEAL 251001Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705011629), received between Jan 22, 2019 and Aug 1, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 1, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ARTHROSCOPIC BANKART REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE TIP ON THE IDEAL SUTURE SHUTTLE 25 DEGREES LEFT DEVICE WAS BROKEN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15138783 ↗
• MalfunctionOct 21, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE AFFILIATE THAT DURING AN UNKNOWN PROCEDURE THE IDEAL SUTURE SHUTTLE 25 DEGREES LEFT-G CAME OFF THE SHAFT RIGHT AFTER THE PROCEDURE STARTED. NOT MUCH TENSION WAS PUT ON THE SUTURE PASSER. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT WITHOUT SURGICAL DELAY. THERE WAS NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW, AND THE FIRST USE WHEN THE ISSUE OCCURRED. IT WAS DISCARDED BY THE STAFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10715642 ↗
• MalfunctionJan 22, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP THAT THE CUSTOMER'S IDEAL SUTURE SHUTTLE 25 DEGREE LEFT FAILED DURING A LABRUM REPAIR SURGICAL PROCEDURE DUE TO THE TIP BEING DENTED THEN IT CRACKED DURING THE PROCEDURE AND THE SURGEON DID NOT THINK IT WOULD WITHSTAND ANOTHER PASS. ACCORDING TO THE REPORTER, THE ANGLED SHAFT CRACKED DURING THE PROCEDURE. ONCE HE REMOVED IT FROM THE JOINT HE FELT AS THOUGH IT CRACKED AND WOULD NOT WITHSTAND ANOTHER PASS. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES OR TIME DELAYS REPORTED. THE DEVICE WILL NOT BE RETURNED AS THE FACILITY DISCARDED IT. 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 8268930 ↗