NA 212114Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705001927), received between Jul 29, 2020 and Oct 20, 2023 — 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.

• MalfunctionOct 20, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL ON AN UNSPECIFIED DATE THE SUPER/ROTCUFF INSERT DEVICE WHEN INSERTING THE ANCHOR USING INSERTER, THE LIGHT BODY OF THE INSTRUMENT BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17977386 ↗
• MalfunctionJul 29, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A BICEPS TENIDOSIS, IT WAS OBSERVED THAT THE TIP OF THE INSERTER SUPER/RC WAS BENT AND BROKE OFF WHEN INSERTING THE ANCHOR INTO THE PATIENT´S BODY. THE ANCHOR WAS SUCCESSFULLY IMPLANTED USING THE SAME DEVICE. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. NO PATIENT CONSEQUENCES OR PROCEDURE DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10339444 ↗