IDEAL 251002Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886705011636), received between Jan 18, 2019 and Nov 24, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 24, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A BANKART REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE IDEAL SUTURE SHUTTLE 25 DEGREES RIGHT DEVICE BROKE DURING USE. ACCORDING TO THE REPORT, THE DISTAL, SILVER, METAL PART SEPARATED FROM THE WHITE, HANDLE PART. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 10 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15863442 ↗
• MalfunctionMay 6, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE WIRE ON THE SUTURE SHUTTLE DEVICE SNAPPED RIGHT AFTER THE BEGINNING OF ITS USE. 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 14310715 ↗
• MalfunctionOct 5, 2021Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE KITE ON THE IDEAL SUTURE SHUTTLE 25 DEGREES RIGHT -G DEVICE COLLAPSED AND GOT OUT OF USE IN SPITE OF PLACING A SUTURE THROUGH THE KITE ONLY ONCE. THERE WERE NO FRAGMENTS OF THE COLLAPSED KITE LEFT IN THE PATIENT'S BODY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12577018 ↗
• MalfunctionSep 16, 2019Break; Break

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A LABRAL/SHOULDER PROCEDURE, IT WAS OBSERVED THE LOOP ON TWO OF THE CUSTOMER'S IDEAL SUTURE SHUTTLES 25 DEGREES RIGHT WERE BROKEN BUT STILL INTACT TO THE DEVICE. THE SALES REP CONFIRMED THAT NOTHING FELL IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A THIRD LIKE DEVICE WITH NO HARM TO THE PATIENT BUT THERE WAS A TEN MINUTE DELAY TO OPEN A NEW DEVICE EACH TIME. THE SALES REP WAS NOT PRESENT FOR THE CASE THEREFORE COULD NOT PROVIDE ANY FURTHER INFORMATION. THE DEVICES WILL BE RETURNING FOR EVALUATION. THERE WAS A DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. 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 WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Not Applicable

  MAUDE report 9069612 ↗
• MalfunctionSep 16, 2019Break; Break

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A LABRAL/SHOULDER PROCEDURE, IT WAS OBSERVED THE LOOP ON TWO OF THE CUSTOMER'S IDEAL SUTURE SHUTTLES 25 DEGREES RIGHT WERE BROKEN BUT STILL INTACT TO THE DEVICE. THE SALES REP CONFIRMED THAT NOTHING FELL IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A THIRD LIKE DEVICE WITH NO HARM TO THE PATIENT BUT THERE WAS A TEN MINUTE DELAY TO OPEN A NEW DEVICE EACH TIME. THE SALES REP WAS NOT PRESENT FOR THE CASE THEREFORE COULD NOT PROVIDE ANY FURTHER INFORMATION. THE DEVICES WILL BE RETURNING FOR EVALUATION. THERE WAS A DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. 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 WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Not Applicable

  MAUDE report 9069611 ↗
• MalfunctionJan 18, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER LABRAL PROCEDURE WHEN REMOVING THE CUSTOMER'S IDEAL SUTURE SHUTTLE 25 DEGREE RIGHT, THE IDEAL SUTURE SHUTTLE 25 DEGREES RIGHT -G DEVICE BROKE ON THE DISTAL TIP. THE SALES REP STATED THAT THE DEVICE BROKE OUTSIDE THE PATIENT. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES BUT THERE WAS A FIVE MINUTE DELAY. THE SALES REP STATED THAT THE DEVICE WAS DISCARDED. 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 8261054 ↗