IDEAL 251004Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10886705011650), received between Jul 11, 2018 and May 28, 2026 — classified as 1 injury, 41 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Unintended Movement

  IT WAS REPORTED THAT DURING AN AUDITORY BRAINSTEM RESPONSE (ABR) PROCEDURE A PIECE OF PLASTIC ATTACHED TO THE GROOVE NEXT TO THE WIRE STORAGE HANDLE OF THE IDEAL SHUTTLE 45 DEGREES RIGHT DEVICE CAME LOOSE. THE LOOSE PLASTIC CAUSED THE WIRE TO CATCH IN THE GROOVE AND HINDERED THE SHUTTLE'S MOVEMENT. THE PROCEDURE WAS COMPLETED USING ANOTHER SHUTTLE. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. 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 25317981 ↗
• MalfunctionMar 20, 2026Break

  THIS IS REPORT OF 2 OF 2 OF (B)(4). TUBING: IT WAS REPORTED THAT DURING AN UNKNOWN ARTHROSCOPIC PROCEDURE IT WAS OBSERVED THAT WHILE USING THE INFLOW TUBING FMS VUE DEVICE, THE IRRIGATION TUBE WAS CONNECTED AND WHEN THE SURGEON PROCEEDED TO PURGE THE IRRIGATION TUBE IN THE PUMP, THE PRESSURE WOULD DROP TO 1 AND THE RESERVOIR WAS COMPLETELY FILLED. MINUTES LATER THE PRESSURE WOULD RETURN TO NORMAL, AND IT WOULD LOOSE PRESSURE AGAIN. SHUTTLE: THE SPECIALIST RECOVERED THE POINT THROUGH THE IDEAL SUTURE SHUTTLE RIGHT 45: WHEN THE SUTURE WAS RAISED, THE CHIA (WIRE) WAS BROKEN WITHOUT ANY TRACTION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF A DELAY TO THE PROCEDURE. 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 24651169 ↗
• MalfunctionFeb 24, 2026Break

  IT WAS REPORTED THAT DURING BANKART REPAIR SHOULDER PROCEDURE, THE IDEAL SHUTTLE 45 DEGREES RIGHT DEVICE THE CHIA WIRE BROKE. NO FRAGMENTS WERE GENERATED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 24432468 ↗
• MalfunctionNov 5, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, WHILE USING THE IDEAL SHUTTLE 45 DEGREES RIGHT -G DEVICE, THE WIRE GOT STUCK INSIDE AND COULD NOT BE REMOVED. IT WAS REPORTED THAT ANOTHER PRODUCT WAS USED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23477571 ↗
• MalfunctionOct 23, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER LABIAPLASTY FOR RECURRENT SHOULDER DISLOCATION, AFTER THE GRYPHON P BR DS ANCHOR W/OC WAS SUCCESSFULLY DEPLOYED, THE SURGEON ATTEMPTED TO SUTURE THE TISSUE, HOWEVER, THE SUTURE BROKE. ANOTHER DEVICE WAS USED TO CONTINUE THE PROCEDURE. IT WAS FURTHER OBSERVED THAT THE TIP OF THE IDEAL SHUTTLE 45 DEGREES RIGHT -G DEVICE WAS BENT AND COULD NOT BE USED. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. IT WAS REPORTED THAT THERE WAS A 30-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 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23368585 ↗
• MalfunctionMay 27, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ROTATOR CUFF REPAIR SURGICAL PROCEDURE WHILE USING THE IDEAL SHUTTLE 45 DEGREES RIGHT -G DEVICE WAS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 22091537 ↗
• MalfunctionMay 5, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE WHILE USING THE IDEAL SHUTTLE 45 DEGREES RIGHT -G DEVICE THE SURGEON OPENED THE PRODUCT AND PULLED THE THREAD AND WIRE TOGETHER ON THE FIRST USE AND THE WIRE BROKE. THERE WAS NO STRONG RESISTANCE, AND IT BROKE WITH A WEAK FORCE. THIS DOES NOT USUALLY HAPPEN. THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS USING A DIFFERENT PRODUCT AND THERE WAS NO RESIDUAL MATERIAL 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 21960700 ↗
• MalfunctionJan 30, 2025Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT TWO IDEAL SHUTTLE 45 DEGREES RIGHT-G DEVICES WERE ¿BENT¿ OUT OF PACKAGING. ACCORDING TO THE REPORTER, ONE DEVICE BENT FURTHER WHEN THE SURGEON ATTEMPTED TO USE IT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A FIVE MINUTE 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 21272451 ↗
• MalfunctionJan 30, 2025Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT TWO IDEAL SHUTTLE 45 DEGREES RIGHT-G DEVICES WERE ¿BENT¿ OUT OF PACKAGING. ACCORDING TO THE REPORTER, ONE DEVICE BENT FURTHER WHEN THE SURGEON ATTEMPTED TO USE IT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A FIVE MINUTE 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 21272450 ↗
• MalfunctionJan 23, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, IT WAS OBSERVED THAT THE IDEAL SUTURE SHUTTLE 45 DEGREES RIGHT DEVICE WAS BENT. 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 21218406 ↗
• MalfunctionJan 15, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC BONEY BANKART REPAIR (ABBR) ON SCAPULA FOR GLENOID FRACTURE SURGICAL PROCEDURE WHILE USING THE IDEAL SHUTTLE 45 DEGREES RIGHT -G DEVICE WHILE RELAYING THE SUTURE, THE WIRE DID NOT COME OUT BECAUSE THE SOFT TISSUE WAS STUCK IN THE TUBE AT THE TIP. THE SURGEON TRIED TO REMOVE THE BLOCKED TIP WITH AN EPIDURAL NEEDLE BUT IT COULD NOT BE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A THIRTY MINUTE DELAY IN THE PROCEDURE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS PATIENT INVOLVEMENT. 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 21157471 ↗
• MalfunctionNov 18, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE FOR A SHOULDER ROTATOR CUFF TEAR, IT WAS DISCOVERED THAT THE TIP OF THE WIRE FROM THE IDEAL SHUTTLE 45 DEGREES RIGHT -G DEVICE BROKE DURING THE FIRST SUTURE RELAY. THE WIRE BROKE, ALTHOUGH THE RESISTANCE WAS SUPPOSED TO BE LOW BECAUSE OF THE ORTHOCORD GENERAL RELAY. 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 20706080 ↗
• MalfunctionNov 11, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, THE IDEAL SHUTTLE 45 DEGREES RIGHT -G DEVICE SUTURE SHUTTLE RING WAS LOOSE. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN (B)(6) 2024. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20657650 ↗
• MalfunctionOct 15, 2024Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE TWO LUPINE LOOP RAPID ANCHOR W/ORTHOCORD DS ANCHOR DEVICES PULL OUT AFTER INSERTION DURING TENSIONING. IT WAS REPORTED THAT TWO LIKE DEVICES WERE USED TO CONTINUE. ALSO, AN IDEAL SUTURE SHUTTLE 45 DEGREES RIGHT DEVICE BROKE AFTER THE FIRST PULL. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THERE WAS A SLIGHT DELAY REPORTED DUE TO OPENING THE SPARE PRODUCTS. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 3 OF 3 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20453325 ↗
• MalfunctionSep 25, 2024Break; Break

  IT WAS REPORTED FROM CHINA THAT DURING THE ROTATOR CUFF REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE PULL LOCK OF THE IDEAL SUTURE SHUTTLE DEVICE, 45 DEGREES RIGHT WAS BROKEN OFF WHEN CROSSING THE LINE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20305054 ↗
• 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 2 OF 2 FOR (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19164357 ↗
• MalfunctionJan 18, 2024Material Deformation; Material Deformation

  IT WAS REPORTED FROM CHINA BY THE SALES REP THAT DURING A SHOULDER REPAIR SURGICAL PROCEDURE ON (B)(6) 2023 THE IDEAL SHUTTLE 45 DEVICE SUTURE SHUTTLE WAS DEFORMED. 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 18533701 ↗
• MalfunctionJan 4, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING A BANKART REPAIR PROCEDURE ON (B)(6) 2023 IT WAS OBSERVED THAT THE IDEAL SUTURE SHUTTLE 45 DEGREES RIGHT DEVICE RING WAS BROKEN OFF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A TWO MINUTE DELAY. 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 18443406 ↗
• MalfunctionAug 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE IDEAL SUTURE SHUTTLE 45 DEGREES RIGHT DEVICE WAS GETTING CAUGHT, SNAPPED AND FELL APART. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. 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 17651867 ↗
• MalfunctionJul 31, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING AN ARTHROSCOPIC STABILIZATION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE WELD ON THE END OF THE IDEAL SUTURE SHUTTLE 45 DEGREES RIGHT DEVICE CAME APART THEN A SHARP PIECE EXTENDED OUT. ACCORDING TO THE REPORT, THE SURGEON WAS STILL ABLE TO FINISH THE PROCEDURE WITH THE DEVICE. 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 17427416 ↗
• MalfunctionMar 1, 2023Packaging Problem; Packaging Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING A BANKART REPAIR PROCEDURE ON (B )(6) 2023, IT WAS OBSERVED THAT THE IDEAL SUTURE SHUTTLE 45 DEGREES RIGHT DEVICE WAS LABELED 251004, LOT # 22C09 BUT WAS ACTUALLY A 45 DEGREE LEFT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A TWO MINUTE DELAY. 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 16461094 ↗
• MalfunctionNov 21, 2022Packaging Problem; Packaging Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER REPAIR SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT A "LEFT" DEVICE WAS INSIDE THE PACKAGING OF THE IDEAL SUTURE SHUTTLE 45 DEGREES RIGHT DEVICE INSTEAD OF A "RIGHT" DEVICE UPON OPENING ITS PACKAGE. 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 15839724 ↗
• MalfunctionSep 30, 2022Break; Break

  THIS IS REPORT 4 OF 6 FOR (B)(4). IT WAS REPORTED BY SALES REP THAT DURING A SHOULDER SCOPE-LABRAL REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT SEVERAL ANCHORS FAILED. ACCORDING TO THE REPORT, THERE WERE THREE LUPINE LOOP RAPIDE ANCHOR W/ORTHOCORD DS DEVICE THAT WERE NOT PROPERLY THREADED THROUGH THE ANCHOR THAT THE SUTURES PULLED COMPLETELY OUT OF ANCHORS UPON INSERTION. IT WAS FURTHER REPORTED THAT WHEN USING A 4TH LUPINE LOOP RAPIDE ANCHOR W/ORTHOCORD DS DEVICE, THE ANCHOR SUTURES WERE NOT THREADED THROUGH THE LOOP THAT THE SURGEON HAD TO PULL ANCHOR OUT OF PATIENT. IT WAS FURTHER REPORTED THAT THE WIRE ON THE IDEAL SUTURE SHUTTLE 45 DEGREES RIGHT DEVICE WAS BROKEN AND UNABLE TO PASS. IT WAS FURTHER REPORTED THAT THE WIRE ON THE IDEAL SUTURE SHUTTLE 45 DEGREES LEFT DEVICE BROKE DURING FIRST PASS AND UNABLE TO BE USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15511105 ↗
• MalfunctionAug 26, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE IDEAL SUTURE SHUTTLE 45 DEGREES RIGHT DEVICE BROKE OFF DURING SUTURE RELAY. 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 15301064 ↗
• MalfunctionAug 1, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED BY THE CUSTOMER IN CHINA THAT DURING A SHOULDER REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE NEEDLE ON THE IDEAL SUTURE SHUTTLE 45 DEGREES RIGHT DEVICE WAS LOOSE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15140560 ↗