FAST-FIX 72202469Recalls & reported problems

Summary

The FDA's MAUDE database contains 561 adverse event reports that list this exact device (DI 00885554023084), received between Aug 18, 2017 and Jul 14, 2026 — classified as 170 injuries, 391 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (163 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 561 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2026Premature Activation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25812645 ↗
• MalfunctionJul 13, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, THE T1 IMPLANT OF ONE (1) FAST-FIX WAS DEPLOYED, AND THE T2 IMPLANT CAME OUT OF THE MENISCUS. 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. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25807952 ↗
• MalfunctionJul 13, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR SURGERY, THE T2 IMPLANT OF ONE (1) FAST-FIX 360 CAME OUT OF THE MENISCUS. T1 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 FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25804230 ↗
• MalfunctionJul 8, 2026Device Dislodged or Dislocated; Firing Problem

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR THE T2 DEPLOYMENT OF ONE (1) FAST-FIX 360 REVERSED CURVE NDL DELIV REQUIRED EXCESSIVE FORCE. AFTER SEVERAL ATTEMPTS IT SLIPPED OUT OF THE MENISCUS. 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 25749619 ↗
• MalfunctionJul 7, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING MENISCUS REPAIR, ONE (1) FAST-FIX 360 REVERSED CURVE NDL DELIV IMPLANT DID NOT DEPLOY AND CAME OUT OF THE MENISCUS. 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 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 25742856 ↗
• MalfunctionJul 1, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR SURGERY, THE T2 IMPLANT OF ONE (1) FAST-FIX 360 DEVICE CAME OUT OF THE MENISCUS. THE T1 IMPLANT WAS REMOVED FROM THE MENISCUS WITH THE ASSISTANCE OF A 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 25678209 ↗
• MalfunctionJun 29, 2026Failure to Fire

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR SURGERY, TWO (2) 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 25648813 ↗
• MalfunctionJun 28, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR, THE T2 IMPLANT OF THREE (3) FAST FIX REVERSE FAILED TO DEPLOY AND GOT STUCK IN THE WHITE CANNULA. 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 25648483 ↗
• MalfunctionJun 28, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR SURGERY, THE IMPLANT OF TWO (2) FAST-FIX GOT DAMAGED AND CAME OUT OF THE MENISCUS. THE T1 IMPLANT WAS DEPLOYED BUT T2 IMPLANT CAME OUT OF THE MENISCUS. THE T1 IMPLANT WAS REMOVED FROM THE PATIENT WITH THE HELP OF A GRASPER. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25647269 ↗
• MalfunctionJun 27, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, THE T1 WAS DEPLOYED OF FOUR (4) FAST-FIX 360 DEVICES, BUT THE T2 CAME OUT OF THE MENISCUS. THE T1S WAS REMOVED 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 25647155 ↗
• MalfunctionJun 20, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR SURGERY, THE T2 IMPLANT OF TWO (2) FAST-FIX 360 REVERSED CURVE NDL DELIV CAME OUT OF THE MENISCUS. 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 25568861 ↗
• MalfunctionJun 18, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A MENISCAL REPAIR SURGERY, THE IMPLANT OF ONE (1) FAST-FIX 360 DID NOT DEPLOY. THE 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, 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 25542315 ↗
• MalfunctionJun 17, 2026Firing Problem

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR PROCEDURE, ONE (1) FAST-FIX 360 REVERSED CURVED T2 IMPLANT DID NOT DEPLOY. 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 25532608 ↗
• MalfunctionJun 13, 2026Firing Problem

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR AND ACL RECONSTRUCTION SURGERY, BOTH IMPLANTS OF ONE (1) FAST-FIX 360 REVERSED CURVE NDL DELIV JUMPED AT THE SAME TIME. 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 25496659 ↗
• MalfunctionJun 13, 2026Failure to Fire

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, THE FAST-FIX 360 CURVED NDL DELIVERY SYS FAILED AT THE TIME OF FIRING THE SECOND SHOT. THE TS WERE REMOVED WITH TWEEZERS. 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 25495678 ↗
• MalfunctionJun 12, 2026Premature Activation

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC MENISCAL REPAIR OF THE KNEE, THE PLATE OF ONE (1) FAST-FIX 360 DEVICE CAME OUT. 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 25494265 ↗
• MalfunctionJun 4, 2026Firing Problem

  IT WAS REPORTED THAT, DURING A SURGERY, BOTH ANCHORS OF THE FAST FIX 360 DEPLOYED DURING THE INITIAL DEPLOYMENT, BUT THEY COULD NOT BE REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY. IT IS UNKNOWN IF THERE WAS A BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 25394673 ↗
• MalfunctionMay 27, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR, AFTER DEPLOYMENT, THE T2 IMPLANT OF ONE (1) FAST-FIX 360 DISLODGED. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED AND WHETHER A SURGICAL DELAY OCCURRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25311165 ↗
• MalfunctionMay 26, 2026Failure to Cycle

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR PROCEDURE, THE FAST FIX'S SPRING DIDN'T REBOUND AFTER DEPLOYMENT. THE T1 WAS SUCCESSFULLY REMOVED. 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 25295866 ↗
• MalfunctionMay 25, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR, AFTER DEPLOYMENT, THE T2 IMPLANT OF ONE (1) FAST-FIX 360 DISLODGED. 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 25273366 ↗
• MalfunctionMay 25, 2026Break

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY MENISCAL SUTURE PROCEDURE, THE FAST FIX'S EXHIBITED A RUPTURE IN THE SUPER-SUTURE; UPON PLACEMENT, IT FAILED TO PASS THROUGH T2, AND IT WAS OBSERVED THAT THE SUPER-SUTURE LACKED CONTINUITY, THEREBY PREVENTING ITS ADJUSTMENT. BOTH T'S WERE REMOVED BY PULLING THEM. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP PRODUCT. PATIENT IS STABLE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25271588 ↗
• MalfunctionMay 19, 2026Failure to Fire

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR SURGERY, T2 IMPLANT OF A FAST-FIX 360 DID NOT DEPLOY. T1 WAS REMOVED FROM THE PATIENT USING GRASPERS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25218449 ↗
• MalfunctionMay 15, 2026Failure to Fire

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE SELF TYING KNOT OF (2) TWO FAST FIX DID NOT REDUCE TO THE MENISCUS. THE T'S WERE PULLED OUT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT BACK UP DEVICE. THE PATIENT STATUS WAS FINE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25190129 ↗
• MalfunctionMay 3, 2026Device Dislodged or Dislocated

  IT WAS REPORTED DURING A MENISCUS REPAIR, THE T1 OF ONE (1) FAST-FIX REVERSE WAS DEPLOYED BUT T2 CAME OUT OF THE MENISCUS. T1 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. 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 25062816 ↗
• InjuryMay 3, 2026Failure to Cycle

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR SURGERY, T1 OF A FAST-FIX 360 CURVED WAS DEPLOYED IN A TYPICAL FASHION, BUT WHEN THE DEVICE WAS INSERTED INTO THE MENISCUS TO PLACE T2 IMPLANT, THE TRIGGER ON THE DEVICE DID NOT ENGAGE TO DELIVER THE IMPLANT. FORWARD PRESSURE ON THE DELIVERY DEVICE IN THE MENISCUS AND FIRING THE TRIGGER WERE ATTEMPTED MULTIPLE TIMES WITHOUT RESULT. THE T2 IMPLANT WAS UNABLE TO BE DELIVERED FROM THE DEVICE. IT WAS ALSO NOTED THAT ON THE FAST-FIX 360 CURVED INSERTER THE PORTION OF THE INSERTER THAT PUSHED THE IMPLANT DOWN THE NEEDLE WAS STUCK IN THE FORWARD POSITION AFTER PLACING THE T1 IMPLANT (CASE (B)(4). THE ISSUE OCCURRED WITH TWO (2) MORE FAST-FIX 360 REVERSED DEVICES (CASE: (B)(4). THE INSERTERS AND SHAFTS WERE NOT BENT DURING THEIR USE. THE SURGEON USED A SUTURE CUTTER TO REMOVE THE SUTURE AND THE T2 IMPLANT WAS VERIFIED TO BE OUT OF THE PATIENT. THE T1 IMPLANT REMAINED UNSECURED ON THE EXTERIOR OF THE JOINT CAPSULE. THE PROCEDURE WAS RESUMED, AFTER A 45-MIN, USING AN ARTHREX INSIDE OUT DOUBLE ARM NEEDLES AND GUIDES COMPETITOR DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25062799 ↗