SUTUREFIX Curved 72204687Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556686287), received between Jan 10, 2019 and Oct 13, 2020 — 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 18, 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 13, 2020Break; Break

  IT WAS REPORTED THAT DURING ARTHROSCOPY THE END OF SUTUREFIX CURVED ANCHOR INSERTER SNAPPED OFF INSIDE THE DRILL GUIDE. ALL PIECES WERE REMOVED FROM THE PATIENT. THERE WAS A DELAY OF UNDER 30 MIN AND THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10668455 ↗
• MalfunctionJan 10, 2019Break

  IT WAS REPORTED THAT DURING THE SHOULDER LABRAL REPAIR, THE SUTURE FIX BROKE INSIDE THE DRILL GUIDE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A BACK UP DEVICE AND NO DELAY REPORTED. IT BROKE INSIDE THE PATIENT BUT THE PIECES WERE REMOVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8236906 ↗