FAST-FIX 72202467Recalls & reported problems

Summary

The FDA's MAUDE database contains 119 adverse event reports that list this exact device (DI 00885554023060), received between May 17, 2017 and Aug 12, 2026 — classified as 40 injuries, 79 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (32 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 119 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Failure to Cycle; Detachment of Device or Device Component

  It was reported that during KNEE ARTHROPLASTY WITH SUTURE surgery, one (1) FAST-FIX 360 STRAIGHT NDL loop failed to deploy when fired. Three unsuccessful attempts were made, resulting in the loop detaching and remaining inside the patient's joint, from where it was subsequently retrieved. 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 50225046 ↗
• MalfunctionJun 29, 2026Failure to Fire

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR SURGERY, ONE (1) FAST-FIX 360 DID NOT DEPLOY THE SECOND PEEK PLATE. T1 WAS REMOVED FROM THE PATIENT USING A LIZARD CLAW. THE PROCEDURE WAS RESUMED, AFTER A 15-MIN SURGICAL DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25648820 ↗
• MalfunctionMar 30, 2026Failure to Fire

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC-ASSISTED ALL-INSIDE MENISCUS REPAIR, DURING THE TRANSITION FROM THE T1 OF A FAST-FIX 360 STRAIGHT NDL DELIVERY SY TO THE T2, THE DEVICE EXPERIENCED A MECHANICAL MALFUNCTION OF THE DEPLOYMENT. UPON ACTIVATING THE TRIGGER FOR T2, IT FAILED TO DEPLOY FROM THE 17-GAUGE NEEDLE TIP. THE SURGEON FOLLOWED THE STANDARD OPERATING PROCEDURE (SOP) FOR DEVICE PREPARATION, INCLUDING PROPER CLICKING OF THE DEPTH LIMITER AND TOGGLING THE DEPLOYMENT SLIDER. THE TRIGGER FELT "MUSHY" OR LACKED THE STANDARD AUDIBLE "CLICK," IT HAD AN INTERNAL DISCONNECTION BETWEEN THE HANDLE TRIGGER AND THE PUSHROD. UPON WITHDRAWAL OF THE DEVICE, THE T-IMPLANT WAS FOUND PARTIALLY LODGED IN THE NEEDLE LUMEN. THE SUTURE WAS NOTED TO BE TANGLED. THE FAILED DEVICE WAS CAREFULLY WITHDRAWN TO ENSURE NO PLASTIC OR SUTURE FRAGMENTS WERE LOST IN THE JOINT SPACE. THE PROCEDURE WAS RESUMED, AFTER A 20-MINUTE DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. ADDITIONAL ANESTHESIA WAS REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24723437 ↗
• MalfunctionDec 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR SURGERY, THE T2 IMPLANT OF THE FAST-FIX 360 CAME OUT OF THE TEAR. 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 23705201 ↗
• MalfunctionNov 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR, BOTH TS OF THE FAST-FIX 360 CAME OUT WHEN THE SURGEON PULLED THE ANCHOR SUTURE. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23677324 ↗
• MalfunctionNov 24, 2025Failure to Fire; Physical Resistance/Sticking; Failure to Fire; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY WITH MENISCAL REPAIR PROCEDURE, AFTER DEPLOYING T1 IMPLANT, THE FILAMENT LEVER WHICH DELIVERS THE IMPLANTS BECAME STUCK AT THE TIP AND DID NOT RETRACT IN ORDER TO DELIVER T2 IMPLANT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23640353 ↗
• InjuryOct 8, 2025Failure to Fire; Physical Resistance/Sticking; Failure to Fire; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR, IT WAS NOTICED THAT THE FAST-FIX 360 T2 IMPLANT COULD NOT BE DEPLOYED. ONCE THE GREY BUTTON WAS PUSHED FORWARD FOR T2, THERE WAS NO ¿CLICK¿ TO DEPLOY THE SECOND ANCHOR, AND THE ANCHOR WAS STUCK IN THE DEVICE SHAFT. THE T1 WAS REMOVED FROM THE PATIENT WITH A GRASPER, AND PULLED ON THE SUTURE AND THE IMPLANT TORE OUT. THE PROCEDURE WAS RESUMED, WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Cartilage damage; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23251640 ↗
• MalfunctionSep 17, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE FIRST ANCHOR OF THE FAST-FIX 360 DEPLOYED BUT THE SECOND ANCHOR DIDN'T WANT TO DEPLOY. SURGEON TRIED 4 TIMES TO DEPLOY THE ANCHOR. THE DEVICE ANCHORS WERE REMOVED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITH A SN BACK UP DEVICE AND IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23075489 ↗
• MalfunctionAug 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, THE T2 IMPLANT OF THE FAST FIX 360 CAME OUT WHILE PULLING THE THREAD. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW 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 22798206 ↗
• MalfunctionAug 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE T2 IMPLANT OF THE FAST-FIX 360 COULD NOT HOLD INTO THE MENISCUS. SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22738990 ↗
• MalfunctionJul 8, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE T2 IMPLANT OF THE FAST-FIX 360 CAME OUT OF THE MENISCUS. SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22437737 ↗
• MalfunctionJun 6, 2025Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, TWO FAST-FIX 360 DEVICES FAILED IN THE SAME WAY AS THE T1 STAPLE DEPLOYED PREMATURELY INTO THE KNEE BEFORE INSERTION INTO THE MENISCUS; THE PROCEDURE WAS COMPLETED WITH A CHANGE IN THE SURGICAL TECHNIQUE, THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22157306 ↗
• MalfunctionMay 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE, WHEN USING THE FAST FIX, THE FIXATION PLATE CAME LOOSE FROM THE CABLE, IT WAS NOT FIXED TO THE HIGH-RESISTANCE WIRE, IT WAS REMOVED WITH A GRASPER. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE. NO DELAY WAS REPORTED AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22047990 ↗
• MalfunctionMay 2, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A MENISCUS SUTURE PROCEDURE, THE FAST-FIX 360 T2 COULD NOT BE DEPLOYED, T1 WAS REMOVED WITH A SHAVER. THE PROCEDURE WAS COMPLETED WITH 1 MINUTE OF SURGICAL DELAY USING A BACK-UP DEVICE. THE PATIENT STATUS IS OKAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21952863 ↗
• MalfunctionMar 27, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR SURGERY, THE FAST-FIX 360´S T2 IMPLANT DID NOT DEPLOY AFTER DEPLOYING THE T1 IMPLANT. THE T1 IMPLANT WAS REMOVED FROM INSIDE THE PATIENT USING A HAND INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21707530 ↗
• MalfunctionFeb 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY WITH ACL FLEXORS, THE FAST-FIX 360 T2 IMPLANT DID NOT ATTACH TO THE MENISCUS WHEN THE SECOND SHOT WAS GIVEN AT THE SECOND SUTURE POINT. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT. SURGERY WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21364042 ↗
• MalfunctionJan 31, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A MENISCUS SUTURE PROCEDURE, THE FAST-FIX 360 STRAIGHT T2 IMPLANT FAILED TO DEPLOY. THE T1 IMPLANT WAS REMOVED FROM THE PATIENT, AND THE SURGERY WAS COMPLETED USING A BACKUP DEVICE. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21287258 ↗
• MalfunctionJan 30, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A MENISCUS SUTURE PROCEDURE, BOTH T-IMPLANTS OF THE FAST-FIX 360 STRAIGHT SLID OFF DURING THE FIRST SHOT. THE T-IMPLANTS WERE REMOVED FROM THE PATIENT. THE SURGERY WAS COMPLETED USING A BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21277256 ↗
• MalfunctionJan 28, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY PROCEDURE, THE T2 IMPLANT OF TWO (2) FAST-FIX 360 REMAINED INSIDE THE HANDLE. THE T1 IMPLANT WAS SUCCESSFULLY REMOVED WITH A GRASPER. SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE INSTEAD. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21261124 ↗
• MalfunctionJan 28, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR SURGERY, THE FAST-FIX 360´S T2 IMPLANT TRIGGERED TOO EARLY, RIGHT AFTER THE T1 IMPLANT. THE T1 IMPLANT WAS DEPLOYED THROUGH THE MENISCUS AND WAS REMOVED FROM INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21251939 ↗
• MalfunctionJan 10, 2025Premature Activation; Premature Activation

  IT WAS REPORTED THAT, DURING MENISCUS SUTURE PROCEDURE, THE FAST-FIX 360 STRAIGHT T2 IMPLANT CAME OUT OF THE BEVEL BEFORE TAKING THE SECOND BITE. THE T1 IMPLANT WAS LEFT INSIDE THE PATIENT, AND T2 WAS REMOVED USING TWEEZERS. THE SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21125536 ↗
• InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER AN ACL AND LEMAIRE PROCEDURE USING A FASTFIX 360, THE PATIENT HAD A STAPHYLOCOCCUS CAPRAE INFECTION. THE PATIENT'S KNEE WAS RINSED OUT WITH ANTIBIOTIC SOLUTION AND THE IMPLANTS REMAINED IN THE PATIENT. 2 X OPENING + RE-OPERATION WITH ARTHROSCOPIC FLUSHING WAS REQUIRED. THE INFECTION WAS CONTROLLED WITH ARTHROSCOPIC RINSING AND ANTIBIOTIC TREATMENT (LEVOFLOXACIN + RIFAMPICIN). THE KNEE IS STABLE WITH PRESERVATION OF ACL RECONSTRUCTION EXPECTED. THE PATIENT CURRENT STATUS IS GOOD.

  Patient problems: Bacterial Infection

  MAUDE report 20344564 ↗
• MalfunctionSep 17, 2024Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY PROCEDURE, AFTER BOTH T´S OF THE FAST-FIX 360 WERE DEPLOYED, IT WAS NOTICED THAT THE KNOT THAT HOLDS THE ANCHORS TOGETHER CAME UNDONE. BOTH TS WERE REMOVED USING GRASPER. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20242038 ↗
• MalfunctionSep 10, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE T1 OF THE FAST FIX WAS DEPLOYED BUT THE T2 DID NOT DEPLOY. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20185845 ↗
• MalfunctionSep 9, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE T1 IMPLANT OF A FAST-FIX 360 WAS DEPLOYED, HOWEVER, T2 COULD NOT BE DEPLOYED. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20170900 ↗