FAST-FIX 72201491Recalls & reported problems

Summary

The FDA's MAUDE database contains 863 adverse event reports that list this exact device (DI 03596010597205), received between Mar 30, 2017 and Jun 2, 2026 — classified as 269 injuries, 594 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (195 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 25 most recent of 863 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, THE T2 IMPLANT OF THE ULTRA FAST FIX COULDN'T BE SECURED AND WAS EASILY PULLED OUT. THE PROCEDURE WAS RESUMED, USING AN S+N EQUIVALENT BACK UP PRODUCT, HOWEVER IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25364573 ↗
• MalfunctionMay 27, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR PROCEDURE, THE FAST FIX'S SECOND IMPLANT CAME OUT WHILE PULLING THE THREAD. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25310927 ↗
• MalfunctionMay 26, 2026Failure to Fire

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR, THE T1 OF AN ULTRA FAST-FIX WAS DEPLOYED SUCCESSFULLY; HOWEVER, AFTER T2 WAS INSERTED INTO THE CORRESPONDING POSITION, IT COULD NOT BE DEPLOYED DESPITE REPEATED ATTEMPTS, RESULTING IN AN UNSUCCESSFUL SUTURE. THE PHYSICIAN THEREFORE HAD TO CUT THE SUTURE THREAD AND REMOVE T1 AS WELL, FROM THE OPPOSITE SIDE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK UP. ADDITIONAL ANESTHESIA WAS NOT REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25295861 ↗
• MalfunctionMay 26, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR, THE T2 OF AN ULTRA FAST-FIX WAS NOT SECURED AND COULD BE PULLED OUT. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACK UP. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25295834 ↗
• MalfunctionMay 25, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR PROCEDURE, THE T2 OF THE ULTRA FASTFIX CAME OUT WHILE PULLING THE THREAD. THE PROCEDURE WAS RESUMED, WITH A NON SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25271817 ↗
• MalfunctionMay 25, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ACL SURGERY, THE SECOND IMPLANT OF ONE (1) ULTRA FAST-FIX CAME OUT WHILE PULLING THE THREAD. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25271803 ↗
• MalfunctionMay 21, 2026Firing Problem

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR, THE T2 OF AN ULTRA FAST-FIX FELL OFF FROM THE INSERTER AFTER T1 WAS DEPLOYED. T1 WAS REMOVED WITH TWEEZERS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. ADDITIONAL ANESTHESIA WAS NOT REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25237934 ↗
• MalfunctionApr 1, 2026Failure to Fire

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR, AFTER THE T1 IMPLANTS OF TWO (2) ULTRA FAST-FIX CURVED WERE DEPLOYED, THE T2 IMPLANTS WERE STUCK IN THE HEAD AND COULD NOT BE DEPLOYED. THE PROCEDURE WAS PERFORMED, USING AN EQUIVALENT S+N BACKUP; HOWEVER, IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24753615 ↗
• MalfunctionMar 31, 2026Firing Problem

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR, BOTH T IMPLANTS OF ONE (1) ULTRA FAST-FIX CURVED FELL OFF AT THE SAME TIME AS THE FIRST DEPLOYMENT. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACKUP, WITH A NON-SIGNIFICANT DELAY. NO ADDITIONAL ANESTHESIA WAS REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24750561 ↗
• MalfunctionMar 25, 2026Firing Problem

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, BOTH TS OF THE ULTRA-FAST-FIX FELL OFF AT THE SAME TIME AS THE FIRST DEPLOYMENT OCCURRED. THE TS WERE NOT DEPLOYED THROUGH THE MENISCUS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. THE PATIENT STATUS IS FINE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24691598 ↗
• MalfunctionMar 24, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, AFTER THE SECOND T OF THE ULTRA-FAST-FIX WAS DEPLOYED, T2 FELL AUTOMATICALLY FROM THE INSERTER. T1 WAS REMOVED FROM THE PATIENT WITH SUCTION. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. THE PATIENT WAS FINE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675818 ↗
• MalfunctionMar 23, 2026Firing Problem

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, BOTH T'S OF THE ULTRA FAST-FIX FELL OFF AT THE SAME TIME AS THE FIRST DEPLOYMENT OCCURRED. THE T;S WERE NOT DEPLOYED THROUGH THE MENISCUS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK-UP. THE PATIENT STATUS IS FINE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663112 ↗
• MalfunctionMar 23, 2026Firing Problem

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, BOTH T'S OF THE ULTRA FAST-FIX FELL OFF AT THE SAME TIME AS THE FIRST DEPLOYMENT OCCURRED. THE T'S WERE NOT DEPLOYED THROUGH THE MENISCUS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK-UP. THE PATIENT STATUS IS FINE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663010 ↗
• MalfunctionFeb 23, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR, THE T2 IMPLANT OF ONE (1) ULTRA FAST-FIX CURVED DID NOT HUNG UP TO THE JOINT CAVITY. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACKUP, WITH A NON-SIGNIFICANT DELAY. NO ADDITIONAL ANESTHESIA WAS REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24414536 ↗
• MalfunctionJan 23, 2026Material Twisted/Bent; Firing Problem

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR, BOTH T'S OF ONE (1) ULTRA FAST FIX CURVED FALL OFF AT THE SAME TIME AT THE FIRST DEPLOYMENT. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACKUP; HOWEVER, IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24168344 ↗
• MalfunctionJan 23, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR, THE T2 ANCHOR OF ONE (1) ULTRA FAST FIX CURVED FELL OFF FROM THE MENISCUS. T1 IMPLANT WAS SUCCESSFULLY REMOVED WITH SUCTION. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACKUP, WITH A NON-SIGNIFICANT DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24168270 ↗
• MalfunctionJan 23, 2026Firing Problem

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR, BOTH T'S OF ONE (1) ULTRA FAST FIX CURVED FELL OFF AT THE SAME TIME DURING THE FIRST DEPLOYMENT. T1 WAS DEPLOYED THROUGH THE MENISCUS AND WAS REMOVED. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACKUP, WITH A NON-SIGNIFICANT DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24167746 ↗
• MalfunctionJan 19, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR SURGERY, TWO (2) ULTRA FAST-FIX T2 IMPLANTS FAILED TO DEPLOY. THE T1 IMPLANT WAS REMOVED FROM INSIDE THE PATIENT USING A GRASPER. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACKUP, AFTER A NON-SIGNIFICANT DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24111923 ↗
• MalfunctionJan 15, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, THE T2 OF ONE (1) ULTRA FAST-FIX FAILED TO DEPLOY. T1 WAS SUCCESSFULLY REMOVED USING GRASPERS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. THE PATIENT'S STATUS IS FINE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24090600 ↗
• MalfunctionJan 15, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, THE ULTRA FAST-FIX T2 IMPLANT DISLODGED. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING AN EQUIVALENT S&N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24079629 ↗
• MalfunctionJan 12, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, THE ULTRA FAST-FIX T2 IMPLANT DISLODGED. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING AN EQUIVALENT S&N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24048376 ↗
• MalfunctionJan 5, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, T2 OF ONE FAST FIX FELL OFF FROM THE MENISCUS. T1 WAS REMOVED WITH SUCTION. THE PROCEDURE WAS RESUMED, AFTER A NON SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23967518 ↗
• MalfunctionDec 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR SURGERY THE ULTRA FAST-FIX T2 IMPLANT FELL OUT FROM THE MENISUCS WHEN PUSHING THE KNOT AFTER SUTURING. IN CONSEQUENCE, BOTH IMPLANTS WERE REMOVED FROM INSIDE THE PATIENT USING SUCTION. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACKUP AFTER A NON-SIGNIFICANT SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23829935 ↗
• MalfunctionDec 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR SURGERY, THE ULTRA FAST-FIX T IMPLANT FELL OUT WHEN PUSHING THE KNOT AFTER SUTURING. BOTH IMPLANTS WERE REMOVED FROM THE INSIDE THE PATIENT USING SUCTION. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACKUP, AFTER A NON-SIGNIFICANT DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23820974 ↗
• MalfunctionDec 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, WHEN THE T2 OF AN ULTRA FAST-FIX WAS DEPLOYED, IT FELL OFF BY ITSELF. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23802530 ↗