FAST-FIX 72205677Recalls & reported problems

Summary

The FDA's MAUDE database contains 88 adverse event reports that list this exact device (DI 00885556804711), received between Dec 30, 2022 and Jul 7, 2026 — classified as 2 injuries, 86 malfunctions.

The most frequently reported specific device problem is “Firing Problem” (33 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 88 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2026Break

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPIC PROCEDURE, WHEN THE SUTURE OF ONE(1) FASTFIX FLEX DEVICE WAS PULLED TO TENSION IT DOWN, THE SUTURE WOULD BREAK. IT IS UNKNOWN IF THERE WAS A S+N BACK UP DEVICE AVAILABLE OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25728615 ↗
• MalfunctionJun 3, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A KNEE MENISCUS REPAIR, THE T2 IMPLANT OF THE FAST FIX CAME OUT DURING DEPLOYMENT. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25386259 ↗
• MalfunctionJun 2, 2026Break

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR PROCEDURE, THE FAST FIX FLEX'S SUTURE BROKE WHILE CLINCHING WHEN REACHING THE 25% ZONE WITHOUT APPLYING ANY EXCESSIVE FORCE. BOTH THE IMPLANTS T1&T2 WERE ALREADY SECURED IN THE PATIENT AND WERE NOT REMOVED. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY, USING A SIMILAR S+N BACK UP. NO PATIENT INJURY OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 25364093 ↗
• MalfunctionJun 1, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR PROCEDURE, WHEN THE NEEDLE OF THE FAST FIX WAS INSERTED INTO THE MENISCUS AND THE DEPLOYMENT KNOB WAS DEPRESSED, T1 FELL FROM THE NEEDLE RAIL AND T2 WOULD NOT BE FIRED. THE PROCEDURE WAS RESUMED, WITH A 3 MINUTE DELAY, USING A SIMILAR SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25352917 ↗
• MalfunctionMay 27, 2026Failure to Advance

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR SURGERY, AFTER BOTH TS OF A FAST-FIX FLEX WERE DEPLOYED, THE KNOT FAILED TO REDUCE. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25311269 ↗
• MalfunctionMay 11, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A SURGERY, THE SECOND IMPLANT OF THE FAST FIX FLEX CAME OUT FROM THE TEAR WHILE PULLING THE THREAD. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25145633 ↗
• MalfunctionMay 11, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A SURGERY, THE T2 OF THE FAST FIX FLEX CAME OUT FROM THE TEAR WHILE PULLING THE THREAD. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25145311 ↗
• MalfunctionMar 26, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A MENISCAL REPAIR, THE T2 IMPLANT OF ONE (1) FAST-FIX FLEX CURVED CAME OUT FROM TEAR WHILE PULLING THE THREAD. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO ADDITIONAL ANESTHESIA WAS REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24703214 ↗
• MalfunctionMar 9, 2026Firing Problem

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION AND MENISCAL REPAIR, THE SECOND IMPLANT OF ONE (1) FAST-FIX FLEX CAME OUT WHILE DEPLOYING THE FIRST IMPLANT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. 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 24543860 ↗
• MalfunctionMar 7, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR T1 WAS DEPLOYED BUT T2 CAME OUT OF THE MENISCUS. T1 WAS REMOVED FROM THE MENISCUS WITH THE HELP OF GRASPER. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING A SIMILAR SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24541653 ↗
• MalfunctionMar 6, 2026Failure to Fire

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE T2 IMPLANT OF THE FAST-FIX FLEX DID NOT DEPLOY. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK-UP. THE PATIENT WAS NOT EXPOSED TO ADDITIONAL ANESTHESIA. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531855 ↗
• MalfunctionJan 28, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR, AFTER THE T1 IMPLANT OF ONE (1) FAST-FIX FLEX CURVED WAS DEPLOYED, THE T2 IMPLANT CAME OUT OF THE MENISCUS. T1 WAS REMOVED FROM THE MENISCUS WITH A GRASPER. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199158 ↗
• MalfunctionJan 28, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR, AFTER THE T1 IMPLANT OF TWO (2) FAST-FIX FLEX CURVED WAS DEPLOYED, THE T2 IMPLANT CAME OUT OF THE MENISCUS. THE T1 IMPLANTS WERE REMOVED FROM THE MENISCUS WITH A GRASPER. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199090 ↗
• MalfunctionJan 23, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR SURGERY, THE FAST FIX FLEX T2 IMPLANT DID NOT DEPLOY. THE PROCEDURE WAS RESUMED, AFTER A NON SIGNIFICANT DELAY, USING A SIMILAR S+N BACK UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24161357 ↗
• MalfunctionJan 16, 2026Firing Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR SURGERY, BOTH TS OF A FAST-FIX FLEX WERE SIMULTANEOUSLY FIRED WHEN THE DEPLOYMENT KNOB WAS DEPRESSED. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACK UP. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY, BUT NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24096014 ↗
• MalfunctionJan 9, 2026Firing Problem

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION AND MENISCAL REPAIR, AFTER DEPLOYING THE FIRST IMPLANT OF TWO (2) FAST-FIX FLEX DEVICES, THE SECOND IMPLANT ALSO CAME OUT OF BOTH INSERTERS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24022773 ↗
• MalfunctionJan 9, 2026Firing Problem

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION AND MENISCAL REPAIR, AFTER DEPLOYING THE FIRST IMPLANT OF ONE (1) FAST-FIX FLEX DEVICE, THE SECOND IMPLANT ALSO CAME OUT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24022657 ↗
• MalfunctionDec 11, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE FAST-FIX FLEX T2 IMPLANT COULD NOT BE DEPLOYED AFTER THE T1 IMPLANT WAS DEPLOYED. THE T1 IMPLANT WAS REMOVED FROM INSIDE THE PATIENT USING A GRASPER. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23785164 ↗
• MalfunctionNov 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR PROCEDURE, IT WAS NOTICED THAT THE T2 IMPLANT OF THE FAST FIX FLEX CAME OUT OF THE MENISCUS, AFTER T1 WAS DEPLOYED. THE T1 IMPLANT WAS REMOVED FROM THE MENISCUS WITH THE HELP OF GRASPER. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23677090 ↗
• MalfunctionNov 28, 2025Failure to Fire; Device Dislodged or Dislocated; Failure to Fire; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR SURGERY, THE T2 IMPLANT OF ONE (1) FAST-FIX FLEX REVERSE CURVED DID NOT DEPLOY AND CAME OUT OF THE MENISCUS. THE T1 IMPLANT WAS DEPLOYED CORRECTLY, HOWEVER IT WAS REMOVED FROM THE MENISCUS WITH THE HELP OF A GRASPER. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO ADDITIONAL ANESTHESIA WAS REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23673987 ↗
• MalfunctionNov 20, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR SURGERY, THE SUTURE ATTACHED TO THE T2 OF ONE (1) FAST-FIX FLEX BECAME TANGLED AND COULD NOT BE DEPLOYED. THE PROCEDURE WAS RESUMED, AFTER A 5 MINUTE DELAY, USING AN EQUIVALENT S+N BACK-UP. 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 23610347 ↗
• MalfunctionNov 18, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, THE T2 IMPLANT OF THE FAST-FIX FLEX DID NOT DEPLOY. THE T1 WAS LEFT SECURED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING AN EQUIVALENT SN BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23585998 ↗
• MalfunctionNov 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR PROCEDURE, THE T2 IMPLANT OF THE FASTFIX FLEX CAME OUT FROM THE TEAR. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT SURGICAL DELAY USING THE SAME S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23451742 ↗
• MalfunctionSep 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE T2 OF THE FAST FIX FLEX CAME OUT WHILE PUTTING IT INTO TEAR. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23015293 ↗
• MalfunctionJul 24, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, WHILE DEPLOYING T1 IMPLANT OF A FAST FIX, BOTH T1 & T2 IMPLANTS GOT DEPLOYED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22601512 ↗