FAST-FIX 72202674Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00885554023169), received between Sep 14, 2017 and Jun 6, 2026 — classified as 7 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (7 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR PROCEDURE, TWO (2) FAST-FIX KNOT PUSHER SUTURE CUTTER, CUT THE SUTURE BEFORE IT WAS TIGHTENED FULLY OR THE CUTTING BLADE WAS DEPLOYED. IT WAS DEEMED THAT THE SUTURES WERE ACCEPTABLE IN POSITION FOR THE FIRST DEVICE AND THAT THEY WERE RETAINED IN PLACE. FOR THE SECOND DEVICE THEY WERE REMOVED. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK UP PRODUCT. ADDITIONAL ANESTHESIA WAS REQUIRED AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25419368 ↗
• MalfunctionApr 7, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR SURGERY, AFTER DEPLOYING TWO (2) FAST-FIX 360, THE SPECIALIST INADVERTENTLY CUT THE SUTURE OF THE IMPLANT BEFORE FULLY TENSIONING THE IMPLANT TO ITS FULL CAPABILITY. BOTH TS WERE REMOVED FROM THE PATIENT USING A SUTURE CUTTER. 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 24802760 ↗
• MalfunctionSep 30, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR PROCEDURE, THE KNOT PUSHER OF THE FASTFIX 360 WAS UNABLE TO CUT THE THREAD OF THE FIRST SUTURE, THEREFORE THE SURGEON USED FORCEPS NOT DESIGNED FOR THIS PURPOSE TO CUT IT; FOR THE SECOND SUTURE, THE SURGEON TRIED AGAIN, BUT IT DID NOT WORK AND BECAME STUCK ON THE SUTURE, WHICH RESULTED IN THE SUTURE BEING TORN OUT, LEADING TO THE REMOVAL OF THE SUTURE PUT IN PLACE; THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACKUP, IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23183851 ↗
• MalfunctionJul 21, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE FAST-FIX'S CARDBOARD BOX WAS OPENED, AND THE INNER PACKAGING WAS ALSO OPEN, INDICATING THE MATERIAL WAS NOT STERILE. IT DID NOT APPEAR TO BE MANIPULATED, AND THE CARTON LABEL WAS INTACT. NO CASE WAS REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22552821 ↗
• MalfunctionNov 1, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR SURGERY, THE FAST-FIX 360S´S SUTURE COULD NOT BE CUT BY THE KNOT PUSHER. BOTH IMPLANTS WERE REMOVED USING A GRASPER. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20588838 ↗
• MalfunctionOct 2, 2024Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE FAST FIX 360 T1 AND T2 WERE DEPLOYED SIMULTANEOUSLY. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE, BUT IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20352063 ↗
• MalfunctionMay 9, 2023Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE FAST FIX DEVICE WAS RECEIVED WITH HOLES IN THE INNER PACKAGING. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16896642 ↗
• InjuryJul 11, 2022Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, AFTER T1 OF THE FAST-FIX 360 WAS IMPLANTED, T2 WAS DEPLOYED SIMULTANEOUSLY. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT SURGICAL DELAY USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14983419 ↗
• InjuryJan 26, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR SURGERY USING A FAST-FIX 360 KNOT PUSHER, AFTER PLACING THE ANCHOR IN THE TISSUE, WHEN ATTEMPTING TO PULL THE SUTURES, THE KNOT DID NOT REDUCE. A KNOT PUSHER WAS USED BUT KNOT WAS UNABLE TO BE MOVED, SO THE ANCHOR HAD TO BE TAKEN OUT. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13358459 ↗
• InjuryJul 20, 2021Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY USING TWO FAST-FIX 360, WHEN THE KNOT PUSHER/SUTURE CUTTER WAS USED, IT DID NOT CUT THE SUTURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A THE SAME DEVICE, BY FORCIBLY PULLING AND CUTTING THE SUTURE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12196011 ↗
• InjuryJul 20, 2021Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY USING TWO FAST-FIX 360, WHEN THE KNOT PUSHER/ SUTURE CUTTER WAS USED, IT DID NOT CUT THE SUTURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A THE SAME DEVICE, BY FORCIBLY PULLING AND CUTTING THE SUTURE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12196010 ↗
• InjuryJun 7, 2021Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, T2 OF THE FAST-FIX 360 COULD NOT BE DEPLOYED FROM NEEDLE. BOTH TS WERE REMOVED. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11952306 ↗
• MalfunctionMar 22, 2021Failure to Cut; Mechanical Jam; Failure to Cut; Mechanical Jam

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, THE USER FOUND OUT THAT THE FAST FIX 360 CUTTER COULD NOT CUT THE FAST FIX 360 IMPLANTS SUTURE SMOOTHLY, THE TRIGGER WAS JAMMED. THE DOCTOR USED A SMITH AND NEPHEW BACK UP DEVICE TO CUT THE SUTURES AND FINISH THE SURGERY. THERE WAS A DELAY OF LESS THAN OR EQUAL TO 30 MIN. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE 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 11542866 ↗
• InjuryDec 6, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING A MENISCAL SUTURE ARTHROSCOPY, THE FAST FIX THREAD CUTTER DID NOT CUT THE THREADS OF THE MENISCUS SUTURES, THEREFORE T2 HAD TO BE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE AND NO DELAY OR FURTHER 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 10955880 ↗
• InjuryNov 12, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING MENISCUS REPAIR SURGERY, THE SUTURE KNOT OF THE STRAIGHT KNOT PUSHER / SUTURE CUTTER AND SLOTTED CANNULA SET WAS CUT OFF DIRECTLY WHEN PUSHING IT AND CUTTING THE SUTURE. THE TS WERE REMOVED. A BACKUP WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR OTHER COMPLICATIONS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10828082 ↗
• MalfunctionNov 2, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE INSTRUMENTS STRUGGLED TO CUT THE FAST FIX SUTURES AND FRAYED. THE MALFUNCTION WAS SOLVED WITH NO DELAYS OR PATIENT HARM USING A BACK UP DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10775358 ↗
• MalfunctionNov 2, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE INSTRUMENTS STRUGGLED TO CUT THE FAST-FIX SUTURES AND FRAYED. THE MALFUNCTION WAS SOLVED WITH NO DELAYS OR PATIENT HARM USING A BACK UP DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10775314 ↗
• MalfunctionDec 23, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE FAST FIX 360 NAIL BROKE. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 9513083 ↗
• MalfunctionJun 7, 2019Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR USING THE FAST-FIX 360, WHEN THE CUT OF THE SUTURE HAS TO BE DONE, THE CUTTER DIDN¿T CUT. BOTH TS WERE REMOVED AND A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY AND NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8679126 ↗
• MalfunctionJun 20, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON WAS DOING A MENISCAL REPAIR USING FASTFIX, KNOT PUSHER DID NOT CUT THE SUTURE. NO BACKUP DEVICE WAS READILY AVAILABLE. NO PROCEDURAL DELAY OR PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7621745 ↗
• MalfunctionSep 27, 2017Premature Activation; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A PROCEDURE USING A FAST FIX 360 DEVICE, THE T1 AND T2 IMPLANTS DEPLOYED SIMULTANEOUSLY. THE PROCEDURE WAS COMPLETED USING A BACKUP DEVICE. THERE WERE NO SIGNIFICANT DELAYS OR PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6897526 ↗
• MalfunctionSep 14, 2017Dull, Blunt

  IT WAS REPORTED THAT THE KNOT PUSHER WAS OPENED AND BLUNT TO CUT THE SUTURE. ENDED UP USING A SEPARATE DEVICE TO CUT. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6865115 ↗
• MalfunctionSep 14, 2017Failure to Cut

  IT WAS REPORTED THAT THE KNOT PUSHER WAS OPENED AND BLUNT TO CUT THE SUTURE. ENDED UP USING A SEPARATE DEVICE TO CUT. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6865111 ↗
• MalfunctionSep 14, 2017Dull, Blunt

  IT WAS REPORTED THAT THE KNOT PUSHER WAS OPENED AND BLUNT TO CUT THE SUTURE. ENDED UP USING A SEPARATE DEVICE TO CUT. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6865103 ↗