MINITAC / DURABRAID 7210303Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010533029), received between Oct 22, 2020 and Aug 13, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A LIGAMENT REPAIR SURGERY, A MINITACTI SUTURE ANCHOR PULLED OUT. SURGERY RESUMED AFTER A NON SIGNIFICANT DELAY, WITH A BACK-UP DEVICE USED IN THE ORIGINALLY DRILLED BONE HOLE, LEAVING NO VOIDS IN THE PATIENT WHOSE BONE QUALITY WAS LOOSE AND CURRENT HEALTH STATUS IS GOOD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17538035 ↗
• MalfunctionApr 12, 2023Break; Break

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, THE MINITAC ANCHOR SUTURE BROKE. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16725550 ↗
• InjuryFeb 28, 2023Break; Break

  IT WAS REPORTED THAT DURING A FINGER REPAIR PROCEDURE, THE MINITACTI 2.0 SCREW BROKE FROM THE RIB. NON-SIGNIFICANT DELAY WAS REPORTED, AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16457332 ↗
• InjuryOct 22, 2020Break; Break

  IT WAS REPORTED THAT DURING SOFT TISSUE FIXATION OF FINGER JOINT PROCEDURE, IT WAS FOUND THAT THE SUTURE WITH NEEDLE WAS BROKEN DURING FIXATION. NO DELAY AND A BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE IN THE SAME BONE HOLE. NO OTHER 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 10720128 ↗