NA 03.226.038Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982077141), received between May 21, 2021 and May 21, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionMay 21, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THAT THE INSTRUMENT WAS IN POOR CONDITION AND CLOSE TO ITS DEFINITIVE EXPIRATION DATE. THE PIECE WAS NOT USED INTRA-SURGICALLY BUT THIS ISSUE WAS DISCOVERED AFTER OPENING THE STERILE PACKAGE. THE TIPS OF THE ANCHOR WERE DEVIATED. THIS REPORT IS FOR ONE (1) COMPRESSION SLEEVE ATTACHMENT FOR 4.5MM HCS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11863560 ↗