FAST-FIX 72205325Recalls & reported problems

Summary

The FDA's MAUDE database contains 133 adverse event reports that list this exact device (DI 00885556780800), received between Nov 22, 2021 and Jul 9, 2026 — classified as 44 injuries, 89 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (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 133 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2026Break

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPIC PROCEDURE, WHEN THE SUTURE OF THE THE 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 25773652 ↗
• InjuryJul 2, 2026Break

  IT WAS REPORTED THAT, DURING A MENISCAL REPAIR SURGERY, AFTER BOTH THE T IMPLANTS OF ONE (1) FAST-FIX FLEX WERE DEPLOYED, THE SUTURE SNAPPED WHILE TENSIONING, BEFORE THE KNOT PUSHER/CUTTER WAS IN THE JOINT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. A MENISCECTOMY WAS DONE INSTEAD OF A REPAIR. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Cartilage damage

  MAUDE report 25696408 ↗
• MalfunctionJun 29, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR PROCEDURE, THE SECOND IMPLANT OF THE FAST FIX FAILED TO DEPLOY ON THE FIRST ATTEMPT BECAUSE IT WAS STUCK WITHIN THE NEEDLE SHAFT. AN ARTHROSCOPIC SCISSOR WAS USED TO CUT THE SUTURE LEFT INSIDE THE MENISCUS'S BODY AND A GRASPER WAS USED TO PULL THE T1 IMPLANT 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 25648781 ↗
• MalfunctionMay 31, 2026Failure to Fire

  IT WAS REPORTED THAT, DURING AN ACL REPAIR, THREE(3) FAST-FIX FLEX DEVICES DID NOT DEPLOY PROPERLY THE T2. T1 WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MINUTES, USING AN OLDER MODEL FAST-FIX 360 TO COMPLETE THE PROCEDURE. ADDITIONAL ANESTHESIA WAS NOT REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 25345339 ↗
• MalfunctionMay 25, 2026Failure to Fire

  IT WAS REPORTED THAT, DURING AN ACL REPAIR, FOUR (4) FAST-FIX FLEX DEVICES DID NOT DEPLOY PROPERLY THE T2 IMPLANT. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MINUTES, USING AN OLDER MODEL FAST-FIX 360 TO COMPLETE THE PROCEDURE. ADDITIONAL ANESTHESIA WAS NOT REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25271953 ↗
• MalfunctionMay 12, 2026Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY WITH MENISCAL REPAIR, AFTER THE T IMPLANTS OF ONE (1) FAST-FIX FLEX WERE DEPLOYED. DURING SUTURE TIGHTENING, THERE WAS UNEXPECTED RESISTANCE WHILE ADVANCING THE SUTURE. A KNOT PUSHER WAS USED TO ACHIEVE THE TENSION, BUT THE SUTURE SNAPPED. DUE TO THE SUTURE FAILURE, THE DEVICE WAS DEEMED NON-FUNCTIONAL FOR COMPLETION OF THE REPAIR. THE IMPLANTED ANCHOR FROM THE INITIAL DEVICE REMAINED IN SITU. BOTH TS WERE SECURE BUT UNABLE TO TIGHTEN PROPERLY. ALL T IMPLANTS WERE LEFT SECURE IN THE PATIENT. 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: Device Embedded In Tissue or Plaque

  MAUDE report 25149249 ↗
• MalfunctionMay 11, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, THE T2 IMPLANT OF THE FAST FIX FLEX FAILED TO DEPLOY. THE PROCEDURE WAS PERFORMED 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 25145449 ↗
• MalfunctionMay 8, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A MENISCAL REPAIR, THE T2 OF A FAST-FIX FLEX CAME OUT FROM MENISCUS WHILE PULLING THE THREAD. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. ADDITIONAL ANESTHESIA WAS NOT REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25125230 ↗
• MalfunctionApr 14, 2026Break

  IT WAS REPORTED THAT, DURING 3-4 PROCEDURES, THE SUTURE OF THE FAST-FIX FLEX DEVICES BROKE OFF WHILE TENSIONING THE KNOT DOWN. THE RESIDUAL SUTURE WAS REMOVED WITH A SHAVER. THERE WERE NON SIGNIFICANT-DELAYS, WITH NO ADDITIONAL ANESTHESIA BEING REQUIRED, AND THE PROCEDURES WERE COMPLETED USING THE SAME DEVICES. IT IS UNKNOWN THE EXACT NUMBER OF PATIENTS WHO EXPERIENCED THIS ISSUE OR THE OUTCOMES FOR THE PATIENTS INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24876182 ↗
• MalfunctionMar 31, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR SURGERY, THE T1 IMPLANT OF ONE (1) FAST-FIX FLEX DEPLOYED SUCCESSFULLY; HOWEVER, WHEN THE DEPLOYMENT KNOB WAS DEPRESSED, THE T2 IMPLANT DID NOT ANCHOR SECURELY AND CAME OFF. 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 24743387 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT, DURING A KNEE MENISCAL REPAIR, THE SUTURE OF THREE (3) UNITS OF THE FST FIX FLX REV CRVD INSRTR BNDR CANN ST WAS BREAKING WHILE TENSIONING IMPLANT DOWN. THEY USED 3 DIFFERENT KNOT PUSHERS/CUTTERS TO RULE THOSE OUT. SUTURE WAS SNAPPING AT SECOND IMPLANT KNOT. NONE OF THE T-IMPLANTS WERE REMOVED FORM THE PATIENT, IT SEEMED TO BE A SUTURE ISSUE NOT IMPLANT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A COMPETITOR DEVICE A STRYKER AIR. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24724138 ↗
• MalfunctionMar 30, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A MENISCAL REPAIR, THE SECOND 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 24715312 ↗
• MalfunctionFeb 21, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR SURGERY, A FAST-FIX FLEX T1 IMPLANT DID NOT LOCK INTO THE MENISCUS, THEY PULLED OUT WHEN PULLING THE SUTURE. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MIN, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24410417 ↗
• MalfunctionFeb 9, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION AND MENISCUS REPAIR PROCEDURE, ONE (1) FAST-FIX FLEX CURVED REVERSE FAILED. AFTER THE T1 IMPLANT WAS SUCCESSFULLY DEPLOYED, WHEN THE DEPLOYMENT KNOB WAS DEPRESSED, THE T2 IMPLANT DID NOT ANCHORED SECURED AND CAME OFF FROM THE MENISCUS. THE PROCEDURE WAS RESUMED, WITH A 5-MINUTE DELAY, USING AN EQUIVALENT S+N BACK-UP. THE PATIENT WAS NOT EXPOSED TO ADDITIONAL ANESTHESIA. PATIENT IS IN RECOVERY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24294562 ↗
• MalfunctionJan 15, 2026Fracture

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR SURGERY, WHEN A FAST-FIX FLEX WAS TRIED TO BE INSERTED INTO THE MENISCUS, THE NEEDLE SPLIT. 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 24088646 ↗
• MalfunctionJan 8, 2026Failure to Fire; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ACL WITH MENISCAL REPAIR PROCEDURE, THE FAST-FIX FLEX DEPLOYMENT MECHANISM WAS STUCK DURING DEPLOYMENT OF THE T2 IMPLANT AND COULD NOT BE MOVED FORWARD, EVEN WHEN THE GREY DEPLOYMENT PLUNGER BOUNCED BACK AFTER DEPLOYING T1. 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 24006429 ↗
• MalfunctionJan 6, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, THE T1 IMPLANT OF THE FAST-FIX FLEX WAS DEPLOYED, BUT T2 CAME OUT OF THE MENISCUS. THE T1 WAS REMOVED FROM THE MENISCUS WITH THE HELP OF GRASPER. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A SIMILAR S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23977109 ↗
• MalfunctionDec 30, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT, DURING A PROCEDURE, BOTH TS OF THE FAST FIX FELL OFF AT THE SAME TIME AS THE FIRST DEPLOYMENT OCCURRED AFTER BENDING. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT SN BACK UP. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23922576 ↗
• MalfunctionDec 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, THE T2 OF THE FAST-FIX FLEX CAME OUT FROM THE TEAR WHILE PULLING. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23687302 ↗
• MalfunctionNov 17, 2025Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE, WHEN THE T2 IMPLANT OF A FAST-FIX FLEX WAS DEPLOYED, IT WAS FOUND THAT THE SUTURE WAS BROKEN. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED, THERE WAS NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569356 ↗
• MalfunctionNov 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, AFTER T1 WAS DEPLOYED FROM TWO (2) FAST-FIX FLEX DEVICES, THE SUTURES WERE VISIBLE, BUT AFTER T2 WAS DEPLOYED, NO SUTURES WERE SEEN AND NO LOOP WAS CREATED FOR T2, ON EITHER DEVICE. BOTH T1S WERE REMOVED WITH A GRASPER AND SHAVER. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. 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 23537736 ↗
• MalfunctionNov 3, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT BEFORE A MENISCUS REPAIR SURGERY, THE PLASTIC PACKAGING OF THE FAST-FIX FLEX WAS FOUND TO BE MELTED WHEN THE BOX WAS OPENED, AND THE STERILE POUCH WAS COMPROMISED. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23451467 ↗
• MalfunctionOct 31, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A MENISCUS ARTHROSCOPIC REPAIR, A FAST-FIX FLEX REVERSE MISFIRED AND SECOND ANCHOR WAS NOT DEPLOYED PROPERLY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE, IT IS UNKNOWN IF THIS CAUSED ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23437635 ↗
• MalfunctionOct 16, 2025Firing Problem; Firing Problem

  IT WAS REPORTED DURING AN ARTHROSCOPY, THE FAST-FIX DEVICE WAS FAULTY, DURING SUTURING, BOTH T IMPLANTS FELL OUT WITH ONE SHOT. THE IMPLANTS WERE REMOVED FROM THE PATIENT WITH THE HELP OF TWEEZERS. THE PROCEDURE WAS RESUMED, AFTER A DELAY LESS THAN OR EQUAL TO 30 MINUTES, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23311582 ↗
• MalfunctionOct 16, 2025Firing Problem; Firing Problem

  IT WAS REPORTED DURING AN ARTHROSCOPY, THE FAST-FIX DEVICE WAS FAULTY, DURING SUTURING, BOTH T IMPLANTS FELL OUT WITH ONE SHOT. THE IMPLANTS WERE REMOVED FROM THE PATIENT WITH THE HELP OF TWEEZERS. THE PROCEDURE WAS RESUMED, AFTER A DELAY LESS THAN OR EQUAL TO 30 MINUTES, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23311115 ↗