NA 214608Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705003914), received between Sep 12, 2018 and Sep 12, 2018 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR, IT WAS OBSERVED THAT THE SHARP TIP OF THE CUSTOMER'S SUTURE LEADER 20 DEGREE UP WAS OPEN AND NOT A CIRCLE ANY LONGER. THE SURGEON NOTICED THAT THE LEADER WAS NOT GRASPING THE SUTURE DURING THE PROCEDURE. WHEN THE SURGEON REMOVED THE DEVICE AND WAS EXAMINING IT WITH ANOTHER INSTRUMENT THE TIP OF THE DEVICE BROKE AND BECAME OPEN-ENDED. THE SALES REP CONFIRMED NOTHING BROKE OFF IN THE PATIENT. THE SURGEON SWITCH TO A PENETRATING GRASPER, STRAIGHT TO COMPLETED THE PROCEDURE WITH NO PATIENT CONSEQUENCES OR DELAY. AFTER THE PROCEDURE IT WAS FOUND THAT THE TIP OF THE GRASPER HAD BECOME BENT. 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 7868290 ↗