FAST-FIX 72201492Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 03596010597212), received between Sep 12, 2017 and Aug 20, 2024 — classified as 17 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (18 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2024Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, THE T2 IMPLANT OF THE ULTRA FAST FIX FELL OFF FROM THE INSERTER. NO DELAY WAS REPORTED AND IT IS UNKNOWN IF THERE WAS A BACK UP DEVICE AVAILABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20008972 ↗
• MalfunctionAug 13, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN THE SURGEON ACTIVATED THE SECOND SUTURE OF THE ULTRA FAST-FIX DID NOT RELEASE AND REMAINED STUCK. THE SUTURE WAS REMOVED WITH TWEEZERS. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT CURRENT STATUS IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19978197 ↗
• MalfunctionJul 1, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SUTURE OF THE ULTRA FAST-FIX BROKE WHEN PUSHED AND KNOT. BOTH IMPLANTS WERE REMOVED FROM THE PATIENT WITH TWEEZERS. THE PROCEDURE WAS COMPLETED WITH A SURGICAL 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 19644718 ↗
• MalfunctionJun 8, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, THE ULTRA FAST-FIX T2 IMPLANT COULD NOT FIRE. THE T1 IMPLANT WAS LEFT SECURED IN THE PATIENT. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A SURGICAL DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19494916 ↗
• MalfunctionMay 27, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR SURGERY, WHEN PLACING THE ULTRA FAST-FIX T2 IMPLANT IN THE MENISCUS IT DID NOT COME OUT OF THE GUIDE, IT WAS TRIED TO PUT THE IMPLANT BACK IN, BUT IT STILL DID NOT COME OUT, SO THE SPECIALIST DECIDED TO REMOVE IT. ALL TS WERE REMOVED WITH A CLAMP. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19402128 ↗
• MalfunctionFeb 5, 2024Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, BOTH IMPLANTS OF THREE (3) ULTRA FAST-FIX WERE FIRED SIMULTANEOUSLY DURING THE FIRST MENISCAL STITCH. ALL THE COMPONENTS WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES. IT IS UNKNOWN IF THERE WAS A BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18640991 ↗
• MalfunctionNov 14, 2023Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE T1 AND T2 IMPLANTS OF THE ULTRA FAST-FIX CAME OUT TOGETHER WHEN DEPLOYED. THE IMPLANTS WERE NOT DEPLOYED THROUGH THE MENISCUS AND WERE REMOVED FROM THE PATIENT WITH ARTHROSCOPICALLY GRASPER. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE WITH NON-SIGNIFICANT SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18133664 ↗
• MalfunctionOct 23, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT, DURING A MENISCUS CASE, THE T2 IMPLANT OF THE ULTRA FAST-FIX COULD NOT BE DEPLOYED. THE T1 IMPLANT WAS REMOVED FROM THE PATIENT'S BODY WITH TWEEZERS. SURGERY WAS COMPLETED AFTER A 10-MINUTE DELAY, USING A BACK-UP DEVICE INSTEAD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17987252 ↗
• MalfunctionSep 22, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR SURGERY, THE T1 OF THE FAST FIX WAS PLACED IN THE MENISCUS TEAR, BUT T2 COULD NOT BE DEPLOYED. T1 & T2 WERE REMOVED FROM THE PATIENT USING A GRASPER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17796607 ↗
• InjuryApr 17, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE T2 ANCHOR OF THE ULTRA FAST-FIX ASSY - REVERSE CURVE COULDN'T BE DEPLOYED. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16753577 ↗
• InjuryMar 6, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, IT WAS NOT POSSIBLE TO DEPLOY THE T2 ON FOUR (4) FAST-FIX DEVICES. T1 WAS LEFT SECURED IN THE PATIENT AND T2 WAS REMOVED WITH A GRASPER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16491895 ↗
• InjuryNov 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON REGISTRY REVIEW 2021 NEW ZEALAND ACL REGISTRY IMPLANT REPORT, AN UNKNOWN AMOUNT OF PATIENTS REQUIRED A REVISION SURGERY AFTER AN ACL PROCEDURE USING TWO(2) ULTRAFASTFIX DEVICES. IT IS UNKNOWN HOW WERE THE EVENTS REDATED/RESOLVED. PATIENTS OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15874581 ↗
• InjuryNov 16, 2022Firing Problem; Firing Problem

  IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, THE SURGEON INSERTED THE ULTRA FAST-FIX INTO THE JOINT SPACE, PENETRATED THE MENISCAL TISSUE AND DEPLOYED T1, HOWEVER, T2 DEPLOYED SIMULTANEOUSLY. BOTH ANCHORS AND SUTURES WERE REMOVED MANUALLY. SURGERY WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY, USING A BACK-UP DEVICE INSTEAD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15806260 ↗
• InjuryAug 17, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR, T2 OF THE FAST-FIX COULD NOT BE DEPLOYED. T1 WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A NON-SIGNIFICANT DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15241288 ↗
• InjuryMay 9, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING USE IN A MENISCUS REPAIR PROCEDURE, THE T2 OF THE FAST-FIX COULD NOT DEPLOYED. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY AND WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14337152 ↗
• InjuryFeb 16, 2022Firing Problem; Firing Problem

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY SURGERY, THE FAST-FIX T2 COULD NOT BE DEPLOYED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13546726 ↗
• InjuryJan 7, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR PROCEDURE, THE T2 OF THE ULTRA FAST-FIX COULD NOT BE DEPLOYED. T1 WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13193272 ↗
• InjuryJul 7, 2021Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING USE INSTRUMENTS INSIDE THE PATIENT, THE ULTRA FAST-FIX REVERSE CURVED IMPLANT FAILED TO DEPLOY, EVEN THOUGH THE SURGEON USED THIS CORRECTLY. THE T2 IMPLANT GOT STUCK AT THE DISTAL TIP OF THE NEEDLE AND COULDN'T BE PUSHED THROUGH, EVEN WITH FORCE OUTSIDE OF THE JOINT SPACE AFTER THE CASE FINISHED. THE PROCEDURE WAS COMPLETED WITH A S+N BACK-UP DEVICE. NO SIGNIFICANT DELAY WAS REPORTED, AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12132288 ↗
• InjuryJul 7, 2021Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING USE INSTRUMENTS INSIDE THE PATIENT, THE ULTRA FAST-FIX REVERSE CURVED IMPLANT FAILED TO DEPLOY, EVEN THOUGH THE SURGEON USED THIS CORRECTLY. THE T2 IMPLANT GOT STUCK AT THE DISTAL TIP OF THE NEEDLE AND COULDN'T BE PUSHED THROUGH, EVEN WITH FORCE OUTSIDE OF THE JOINT SPACE AFTER THE CASE FINISHED. THE PROCEDURE WAS COMPLETED WITH A S+N BACK-UP DEVICE. NO SIGNIFICANT DELAY WAS REPORTED, AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12132225 ↗
• InjuryJul 7, 2021Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING USE INSTRUMENTS INSIDE THE PATIENT, THE ULTRA FAST-FIX REVERSE CURVED IMPLANT FAILED TO DEPLOY, EVEN THOUGH THE SURGEON USED THIS CORRECTLY. THE T2 IMPLANT GOT STUCK AT THE DISTAL TIP OF THE NEEDLE AND COULDN'T BE PUSHED THROUGH, EVEN WITH FORCE OUTSIDE OF THE JOINT SPACE AFTER THE CASE FINISHED. THE PROCEDURE WAS COMPLETED WITH A S+N BACK-UP DEVICE. NO SIGNIFICANT DELAY WAS REPORTED, AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12131557 ↗
• InjuryJul 7, 2021Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING USE INSTRUMENTS INSIDE THE PATIENT, THE ULTRA FAST-FIX REVERSE CURVED IMPLANT FAILED TO DEPLOY, EVEN THOUGH THE SURGEON USED THIS CORRECTLY. THE T2 IMPLANT GOT STUCK AT THE DISTAL TIP OF THE NEEDLE AND COULDN'T BE PUSHED THROUGH, EVEN WITH FORCE OUTSIDE OF THE JOINT SPACE AFTER THE CASE FINISHED. THE PROCEDURE WAS COMPLETED WITH A S+N BACK-UP DEVICE. NO SIGNIFICANT DELAY WAS REPORTED, AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12131436 ↗
• InjuryJul 7, 2021Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING USE INSTRUMENTS INSIDE THE PATIENT, THE ULTRA FAST-FIX REVERSE CURVED IMPLANT FAILED TO DEPLOY, EVEN THOUGH THE SURGEON USED THIS CORRECTLY. THE T2 IMPLANT GOT STUCK AT THE DISTAL TIP OF THE NEEDLE AND COULDN'T BE PUSHED THROUGH, EVEN WITH FORCE OUTSIDE OF THE JOINT SPACE AFTER THE CASE FINISHED. THE PROCEDURE WAS COMPLETED WITH A S+N BACK-UP DEVICE. NO SIGNIFICANT DELAY WAS REPORTED, AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12131423 ↗
• InjuryJul 7, 2021Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING USE INSTRUMENTS INSIDE THE PATIENT, THE ULTRA FAST-FIX REVERSE CURVED IMPLANT FAILED TO DEPLOY, EVEN THOUGH THE SURGEON USED THIS CORRECTLY. THE T2 IMPLANT GOT STUCK AT THE DISTAL TIP OF THE NEEDLE AND COULDN'T BE PUSHED THROUGH, EVEN WITH FORCE OUTSIDE OF THE JOINT SPACE AFTER THE CASE FINISHED. THE PROCEDURE WAS COMPLETED WITH A S+N BACK-UP DEVICE. NO SIGNIFICANT DELAY WAS REPORTED, AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12131336 ↗
• InjuryJul 6, 2021Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING USE INSTRUMENTS INSIDE THE PATIENT, THE ULTRA FAST-FIX REVERSE CURVED IMPLANT FAILED TO DEPLOY, EVEN THOUGH THE SURGEON USED THESE CORRECTLY. THE T2 IMPLANT GOT STUCK AT THE DISTAL TIP OF THE NEEDLE AND COULDN'T BE PUSHED THROUGH, EVEN WITH FORCE OUTSIDE OF THE JOINT SPACE AFTER THE CASE FINISHED. THE PROCEDURE WAS COMPLETED WITH A S+N BACK-UP DEVICE. NO SIGNIFICANT DELAY WAS REPORTED, AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12124986 ↗
• InjuryApr 23, 2021Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING MENISCUS REPAIR SURGERY, THE ULTRA FAST-FIX ASSY - REVERSE CURVE FAILED TO DEPLOY CORRECTLY. T1 WAS DEPLOYED, T2 THEN WOULDN¿T DEPLOY AND GOT STUCK ON THE END OF THE NEEDLE INSERTED. T1 WAS REMOVED FROM THE PATIENT. THE SURGERY WAS COMPLETED WITH A BACKUP DEVICE, AND A DELAY OF 30 MINUTES OR LESS. NO PATIENT COMPLICATIONS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11715979 ↗