NA 214611Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705003945), received between Nov 15, 2023 and May 16, 2026 — classified as 3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionMay 16, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC BANKART REPAIR (ABR) PROCEDURE FOR A LABRAL TEAR, IT WAS OBSERVED THAT THE TIP OF THE ARTHRO SUTURE LDR 45 RIGHT SUTURING DEVICE BROKE WHEN USED TO SUTURE THE LABRUM. IT WAS REPORTED THAT THE BREAK OCCURRED WHILE SUTURING SOFT TISSUE, NOT BONY BANKART TISSUE. IT WAS REPORTED THAT THERE WERE NO INTERNAL IMPLANTS IN THE PATIENT. THE SURGERY WAS SUCCESSFULLY COMPLETED USING A DIFFERENT PASSER. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25195145 ↗
• MalfunctionJul 18, 2025Break; Break

  IT WAS REPORTED THAT DURING AN AUDITORY BRAINSTEM RESPONSE (ABR) SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING THE ARTHRO SUTURE LDR 45 RIGHT EA DEVICE, THE SURGEON PASSED A RELAY SUTURE INTO THE SOFT TISSUE USING THE SUTURE LEADER. AT THE TIME OF THE PROCESS, THE DEVICE WAS BEING SLID OVER THE SURFACE OF THE SHOULDER BLADE, AND IT SUDDENLY BROKE OFF. THE BROKEN PART WAS IDENTIFIED UNDER ARTHROSCOPY AND WAS QUICKLY REMOVED FROM THE BODY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS EXTENDED BUT NOT BEYOND THIRTY MINUTES. 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 22545700 ↗
• MalfunctionNov 15, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT ON AN UNKNOWN DATE IT WAS OBSERVED THAT THE SHAFT OF THE ARTHRO SUTURE LDR 45 RIGHT *EA DEVICE WAS BENT AND NOTED THAT THERE WAS A RISK OF INTRAOPERATIVE DAMAGE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18142113 ↗