FAST-FIX 72201490Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010610904), received between Apr 18, 2018 and Jul 11, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR SURGERY, WHEN THE ULTRA FAST FIX T1 WAS DEPLOYED, AFTER REMOVING THE INSERTER FROM THE MENISCUS AND PRIMING T2, T2 FELL OFF THE INSERTER AND WAS LOOSE IN THE KNEE. THE T1 IMPLANT WAS LEFT SECURED IN THE PATIENT, AND THE SUTURE ON T2 WAS CUT USING ARTHROSCOPIC SCISSORS. IT WAS THEN REMOVED WITH A GRASPER FROM THE PATIENT'S KNEE. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19719933 ↗
• InjuryOct 20, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A KNEE PROCEDURE, THE ULTRA FAST-FIX FAILED. T1 DEPLOYED ACCURATELY. THE T2 SAT PROUD UNDER MENISCUS AND WOULD HAVE CAUSED IRRITATION AS IT WAS LOOSE. THE T WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. NO SIGNIFICANT DELAY AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12669268 ↗
• MalfunctionNov 7, 2018Loose or Intermittent Connection

  IT WAS REPORTED THAT THE DEVICE FORM FAILED TO LOCK BEHIND THE MENISCUS, THE FIRST ANCHOR CAUGHT ON THE BACK SIDE OF THE MENISCUS AS IT SHOULD, BUT THE SECOND ONE CAME OUT THEN THE DEVICE WAS WITHDRAWN. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8046037 ↗
• MalfunctionNov 6, 2018Loose or Intermittent Connection

  IT WAS REPORTED THAT THE DEVICE FORM FAILED TO LOCK BEHIND THE MENISCUS, THE FIRST ANCHOR CAUGHT ON THE BACK SIDE OF THE MENISCUS AS IT SHOULD, BUT THE SECOND ONE CAME OUT THEN THE DEVICE WAS WITHDRAWN. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8042051 ↗
• MalfunctionApr 18, 2018Positioning Failure

  IT WAS REPORTED THAT T2 DID NOT DEPLOYED. THERE WAS NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7439901 ↗