NA 214613Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886705003969), received between Jul 3, 2018 and Apr 15, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2026Material Deformation

  THIS IS REPORT 1 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, THE SURGICAL TEAM UTILIZED THE MITEK SUTURE LEADER RIGHT 70 DEGREE INSTRUMENT TO PASS SUTURE THROUGH TISSUE. THE SURGEON ATTEMPTED TO USE THE INSTRUMENT THREE TIMES BUT WAS UNSUCCESSFUL IN PASSING THE SUTURE. THE SURGEON OBSERVED THAT THE INSTRUMENT WAS BENT AT THE DISTAL TIP, RENDERING IT UNUSABLE. ANOTHER TRAY WAS OPENED TO OBTAIN THE SAME INSTRUMENT FROM A DIFFERENT SET. DESPITE REPEATING THE ATTEMPT, THE SUTURE COULD NOT BE PASSED, AND THE SECOND INSTRUMENT WAS BENT AT THE TIP. TO COMPLETE THE PROCEDURE, A COMPETITOR'S DISPOSABLE PRODUCT WAS EMPLOYED. THIS SUBSTITUTION RESULTED IN A 10-MINUTE DELAY, BUT NO PATIENT HARM OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24883021 ↗
• MalfunctionApr 15, 2026Material Deformation

  THIS IS REPORT 2 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, THE SURGICAL TEAM UTILIZED THE MITEK SUTURE LEADER RIGHT 70 DEGREE INSTRUMENT TO PASS SUTURE THROUGH TISSUE. THE SURGEON ATTEMPTED TO USE THE INSTRUMENT THREE TIMES BUT WAS UNSUCCESSFUL IN PASSING THE SUTURE. THE SURGEON OBSERVED THAT THE INSTRUMENT WAS BENT AT THE DISTAL TIP, RENDERING IT UNUSABLE. ANOTHER TRAY WAS OPENED TO OBTAIN THE SAME INSTRUMENT FROM A DIFFERENT SET. DESPITE REPEATING THE ATTEMPT, THE SUTURE COULD NOT BE PASSED, AND THE SECOND INSTRUMENT WAS BENT AT THE TIP. TO COMPLETE THE PROCEDURE, A COMPETITOR'S DISPOSABLE PRODUCT WAS EMPLOYED. THIS SUBSTITUTION RESULTED IN A 10-MINUTE DELAY, BUT NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24883019 ↗
• 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 70 LEFT *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 18140909 ↗
• MalfunctionJul 3, 2018Break; Break

  THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. TIP WAS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7658210 ↗