LCP 222.221Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982156532), received between Jan 22, 2019 and Jan 22, 2019 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2019Break; Break

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING SHOULDER ARTHROSCOPY SURGICAL PROCEDURE, IT WAS OBSERVED THAT TWO STITCHES OF 6.5 HEALIX PEEK ANCH W/ OC SUTURE DEVICE BROKE INSIDE THE PATIENT. ACCORDING TO THE REPORTER, NO INSTRUMENT CAME INTO CONTACT WITH THE SUTURE TO CAUSE BREAKAGE. IT WAS FURTHER REPORTED THAT THE SURGEON PUT THE IMPLANT BUT NO SUTURE BECAUSE IT HAD BEEN BROKEN. IT WAS REPORTED THAT THE SURGEON WAS SATISFIED WITH THE FIXATION. IT WAS REPORTED THAT THE PROCEDURE TIME WAS EXTENDED 30 MINUTES. 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 8267642 ↗
• MalfunctionJan 22, 2019Break; Break

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING SHOULDER ARTHROSCOPY SURGICAL PROCEDURE, IT WAS OBSERVED THAT TWO STITCHES OF 6.5 HEALIX PEEK ANCH W/ OC SUTURE DEVICE BROKE INSIDE THE PATIENT. ACCORDING TO THE REPORTER, NO INSTRUMENT CAME INTO CONTACT WITH THE SUTURE TO CAUSE BREAKAGE. IT WAS FURTHER REPORTED THAT THE SURGEON PUT THE IMPLANT BUT NO SUTURE BECAUSE IT HAD BEEN BROKEN. IT WAS REPORTED THAT THE SURGEON WAS SATISFIED WITH THE FIXATION. IT WAS REPORTED THAT THE PROCEDURE TIME WAS EXTENDED 30 MINUTES. 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 8267640 ↗