FAST-FIX 72205324Recalls & reported problems

Summary

The FDA's MAUDE database contains 383 adverse event reports that list this exact device (DI 00885556772737), received between Aug 16, 2021 and Jul 7, 2026 — classified as 90 injuries, 293 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (112 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 383 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2026Break

  IT WAS REPORTED THAT, DURING AN ACL MENISCAL REPAIR SURGERY, ONE(1) FAST FIX FLX CRVD INSRTR BNDR CANN SET WAS INSERTED INTO THE MENISCUS USING THE FLEXPISTOL. BOTH IMPLANTS WERE DEPLOYED SUCCESSFULLY; WHEN THE SUTURE WAS PULLED TO REDUCE THE TEAR, THE SUTURE SNAPPED. THE FAST-FIX FLEX WAS THEN ABANDONED AND SURGEON WENT WITH FAST-FIX 360. MENISCAL TEAR WAS REPAIRED WITHOUT FURTHER INCIDENT. 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 25728742 ↗
• MalfunctionJul 4, 2026Failure to Cycle

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY SURGERY, ONE (1) FAST-FIX FLEX WAS UNABLE TO BUILD TENSION AFTER DEPLOYMENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP PRODUCT. ALTHOUGH THERE WAS AN ISSUE WITH THE IMPLANT, BOTH T IMPLANTS REMAIN INSIDE THE PATIENT¿S MENISCUS AND WERE NOT REMOVED. 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 25712104 ↗
• MalfunctionJun 10, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, THE T2 IMPLANT OF THE FAST FIX CAME OUT FROM 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 25462945 ↗
• MalfunctionJun 8, 2026Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE ANCHORS OF A FAST-FIX FLEX WERE DEPLOYED SUCCESSFULLY. DURING THE SUTURE TIGHTENING PHASE, THE SURGEON ACHIEVED ADEQUATE TENSION, A KNOT PUSHER WAS USED IN ACCORDANCE WITH STANDARD INTRAOPERATIVE TECHNIQUE. DURING THIS MANEUVER, THE SUTURE SNAPPED UNDER TENSION, THE DEVICE WAS DEEMED NON-FUNCTIONAL FOR COMPLETION OF THE REPAIR. THE PIECES WERE REMOVED WITH A GRASPER.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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25438488 ↗
• MalfunctionJun 2, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A SURGERY, AFTER DEPLOYMENT OF THE 2 ANCHORS OF TWO FAST FIX FLEX, WHILE PULLING ON THE TENSION SUTURE IT COMPLETELY DISENGAGED FROM THE IMPLANT PREVENTING THE REQUIRED TENSIONING FROM BEING ACHIEVED WITH THE IMPLANT, AND REQUIRING ANOTHER TO BE USED TO APPLY TENSION. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25368453 ↗
• MalfunctionJun 2, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, THE T2 IMPLANT OF ONE (1) FAST FIX FLEX COULD NOT BE FIRED. T1 WAS SUCCESSFULLY REMOVED USING GRASPERS. THE PROCEDURE WAS PERFORMED, 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 25356909 ↗
• MalfunctionJun 1, 2026Break

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, A FAST-FIX FLEX SUTURE BROKE AT INTERFACE OF THE SLIDING KNOT. THE PROCEDURE WAS RESUMED, AFTER A 2-MIN SURGICAL DELAY, USING AN EQUIVALENT S+N BACK-UP. 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 25350294 ↗
• MalfunctionMay 31, 2026Firing Problem

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, BOTH IMPLANTS OF ONE (1) FAST FIX FLEX CURVED EJECTED WITH A SINGLE FIRE. THE SUTURE WAS CUT AND REIMPLANTING WAS PERFORMED. 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 25342883 ↗
• MalfunctionMay 27, 2026Firing Problem

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, BOTH IMPLANTS OF ONE (1) FAST FIX FLEX CURVED EJECTED WITH A SINGLE FIRE. THE SUTURE WAS CUT AND REIMPLANTING WAS PERFORMED. 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 25305801 ↗
• MalfunctionMay 26, 2026Failure to Fire

  IT WAS REPORTED THAT, DURING AN ACL REPAIR, THREE (3) FAST-FIX FLEX DEVICES DID NOT DEPLOY PROPERLY THE T2. 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 25295873 ↗
• MalfunctionMay 25, 2026Break

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, THE PULL CORD OF TWO (2) FAST FIX CURVED SNAPPED WHEN IT WAS TIGHTENED SLIGHTLY. BOTH TS WERE REMOVED. THE PROCEDURE WAS PERFORMED, 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 25273363 ↗
• InjuryMay 21, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A SURGERY, DURING THE FAST FIX FLEX IMPLANT DEPLOYMENT, WHEN TENSION WAS APPLIED TO THE REPAIR SUTURE, THE REPAIR STITCH SLIPS OFF, APPEARING AS THOUGH THERE IS LITTLE TO NO TENSION. DOCTOR HAD TO SHAVE OUT THE SUTURE LOOPS AND LEAVE THE IMPLANTS IN THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25244221 ↗
• MalfunctionMay 19, 2026Failure to Fire

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR, THE T2 OF A FAST-FIX FLEX DID NOT DEPLOY CORRECTLY. T1 WAS SUCCESSFULLY REMOVED FROM THE PATIENT USING A GRASPER. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN ARTHREX FIBERSTITCH DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25217353 ↗
• MalfunctionMay 18, 2026Break

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, THE PULL CORD OF ONE (1) FAST FIX CURVED SNAPPED WHEN IT WAS TIGHTENED SLIGHTLY. BOTH TS WERE REMOVED. THE PROCEDURE WAS PERFORMED, 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 25211640 ↗
• MalfunctionMay 18, 2026Break

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR SURGERY, TWO (2) FAST-FIX FLEX TENSION SUTURE BROKE AND FELL OUT WHILE TENSIONING THE SELF-TYING KNOT. THE TS WERE NOT REMOVED, THEY REMAINED SECURED INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 25202969 ↗
• MalfunctionMay 14, 2026Break

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR SURGERY, TWO (2) FAST-FIX FLEX WERE DEPLOYED PROPERLY, BUT WHEN THE SPECIALIST BEGAN TENSIONING THE SUTURE BROKE EARLY, LEAVING A LONG TAIL OFF THE KNOT STACK. THE TAIL WAS SHORTENED WITH A BITER AND A SHAVER TO REDUCE THE LENGTH. THE PROCEDURE WAS RESUMED, AFTER A 5-MIN SURGICAL DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25172724 ↗
• MalfunctionMay 11, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, THE T2 IMPLANT OF THE FAST FIX FELL OFF WHEN TIGHTENING UP THE SUTURE. THE T1 IMPLANT WAS LEFT SECURED IN THE PATIENT. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 25145427 ↗
• MalfunctionMay 11, 2026Break

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR, THE SUTURE OF A FAST-FIX FLEX BROKE, IT TORE. THE BROKEN PIECES WERE REMOVED USING TWEEZERS. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25145158 ↗
• MalfunctionMay 6, 2026Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE SUTURE OF THE FAST-FIX FLEX BROKE WHILE BEING TIGHTENED. THERE WAS A RISK OF MENISCUS INJURY. THE PROCEDURE WAS RESUMED, 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 25093880 ↗
• MalfunctionMay 1, 2026Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION AND MENISCAL REPAIR, THE SUTURE OF ONE (1) FAST FIX FLX CRVD INSRTR BNDR CANN SET BROKE BEFORE THE KNOTTING PROCEDURE WAS COMPLETED. THE PROCEDURE WAS RESUMED, 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 25062381 ↗
• MalfunctionApr 29, 2026Failure to Fire

  IT WAS REPORTED THAT, DURING A SURGERY, THE T2 OF THE FAST FIX FLEX COULD NOT BE DEPLOYED. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT SN BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25029813 ↗
• MalfunctionApr 29, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, THE FAST-FIX FLEX IMPLANTATION OF THE SECOND DEPLOYMENT WAS UNSUCCESSFUL AS THE IMPLANT WAS STUCK FROM THE TISSUE, RESULTING IN A FAILURE IN DEPLOYMENT. 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 25029785 ↗
• MalfunctionApr 28, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A MENISCAL REPAIR, THE T2 OF A FAST FIX FLEX CAME OUT FROM TEAR 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 25024193 ↗
• MalfunctionApr 27, 2026Break

  IT WAS REPORTED THAT, DURING A SURGERY, WHILE ATTEMPTING TO APPLY TENSION TO THE FAST FIX FLEX SUTURE, IT BROKE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR SN BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25010194 ↗
• MalfunctionApr 27, 2026Break; Failure to Fire

  IT WAS REPORTED THAT DURING MENISCUS REPAIR SURGERY, THE FIXATION ROD OF TWO (2) FAST-FIX FLEX FAILED TO FULLY POP OUT, RESULTING IN THE INABILITY TO PROPERLY FIX THE MENISCUS. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACKUP. IT IS UNKNOWN WHETHER ANY DELAY OCCURRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25010117 ↗