QFIX 1.8 MINI SUTURE 72290124Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556662625), received between Jan 13, 2021 and Jun 19, 2023 — classified as 2 injuries.

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.

• InjuryJun 19, 2023Break; Break

  IT WAS REPORTED THAT, DURING A MENISCAL CENTRALIZATION SURGERY, THE DISTAL TIP OF THE SUTURE ANCHOR DRILL BROKE WHEN THE DRILL WAS BEING USED TO MAKE A BONE HOLE. SURGEON CHECKED THE IMAGE AND A METAL PIECE WAS LEFT IN THE TIBIA. THE BROKEN DRILL WAS REMOVED FROM THE PATIENT. SURGERY WAS COMPLETED AFTER A 15-MINUTE DELAY, HOWEVER, IT IS UNKNOWN IF A BACK-UP DEVICE WAS AVAILABLE, NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17153190 ↗
• InjuryJan 13, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN ANTERIOR TALOFIBULAR LIGAMENT REPAIR PROCEDURE, THE DRILL OF DISTAL TIP OF THE "1.8MM Q-FIX SUTURE ANCHOR" INTERFERED WITH THE DRILL GUIDE, ABOUT 10MM OF THE DRILL TIP WAS BROKEN INSIDE THE BODY. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11166746 ↗