NOVOSTITCH CTX-A003Recalls & reported problems

Summary

The FDA's MAUDE database contains 98 adverse event reports that list this exact device (DI 00853541006112), received between Nov 28, 2018 and May 28, 2026 — classified as 46 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Break” (62 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 98 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, NOVOSTITCH SUTURE BROKE AFTER THE DEPLOYMENT. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED; OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25318561 ↗
• MalfunctionFeb 18, 2026Break

  IT WAS REPORTED THAT, DURING A LEEP PROCEDURE, A NOVOSTITCH WAS DEPLOYED AND IT WAS NOTICED THAT THE TIP CAME LOOSE AND BROKE AWAY FROM THE POLE UPON REMOVAL FROM THE PATIENT. ONE PIECE WAS ABLE TO BE RECOVERED. X-RAYS WERE TAKEN BY PROTOCOL AND NO FOREIGN BODIES WERE RETAINED. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED; HOWEVER, NO SURGICAL DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24381611 ↗
• MalfunctionJan 27, 2026Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE LOWER JAW OF A NOVOSTITCH DEVICE WOULD NOT MOVE, AND THE TIP EASILY BROKE OFF, MAKING IT UNUSABLE EVEN AFTER REPLACING THE CARTRIDGE. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT. 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 24190799 ↗
• MalfunctionSep 29, 2025Break; Break

  IT WAS REPORTED THAT, DURING A MENISCAL ARTHROSCOPIC PROCEDURE, IT WAS NOTICED DURING POSITIONING OF THE SECOND SUTURE THAT THE NOVOSTITCH WAS BROKEN. NO PARTS WERE LEFT INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITH 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 23166956 ↗
• InjurySep 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON REGISTRY REVIEW "2025 NEW ZEALAND ACL REGISTRY IMPLANT REPORT", AN UNKNOWN NUMBER OF PATIENTS HAD A FAILURE OF THE IMPLANTS AFTER AN ACL PROCEDURE WHERE TWO (2) NOVOSTITCH PRO DEVICES WERE USED. PATIENTS REQUIRED REVISION SURGERY. PATIENTS OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 23062872 ↗
• MalfunctionSep 12, 2025Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A REPAIR OF A RADIAL MENISCAL TEAR, THE LATERAL JAW OF THE NOVOSTITCH PRO MEN WAS STIFF TO DEPLOY. THE SURGEON WAS ABLE TO DEPLOY FIRST PASS, BUT THE SECOND PASS DID NOT CAPTURE. WHEN THE CARTRIDGE WAS RELOADED, IT WAS FOUND THAT THE NEEDLE HAD SEPARATED FROM FIRST CARTRIDGE AND FELL OUTSIDE THE PATIENT, THERE WAS NO REMNANTS OF THE NEEDLE LEFT IN PATIENT. THERE WAS CHANGE IN THE SURGICAL TECHNIQUE AS SURGEON WENT TO INSIDE OUT WITH OUR MENISCAL STITCHER SET, SECURING WITH A COMBINATION OF FAST FIX FLEX AND FAST FIX 360, WITH A DELAY LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23042544 ↗
• MalfunctionSep 5, 2025Break; Break

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR, THE TRAP DOOR OF THE NOVOSTICTCH DEVICE WHICH THE SUTURE PASSES HAS BROKEN OFF INSIDE THE PATIENT WHILE DEPLOYING. THE BROKEN PARTS WERE REMOVED FROM THE PATIENT USING A GRASPER. THE SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22985292 ↗
• MalfunctionJun 30, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE NOVOSTITCH PRO MENISCAL REPAIR SYSTEM'S FIRST LOAD WAS CAPTURED PROPERLY, BUT THE CARTRIDGE BROKE IN HALF PRIOR TO THE SECOND CAPTURE WHILE STILL ATTACHED TO THE NOVOSTITCH HANDLE AS THE DOCTOR WAS ATTEMPTING INSERTION INTO THE MENISCUS, RESULTING IN AN INCOMPLETE REPAIR. THE SURGERY WAS COMPLETED USING A BACKUP DEVICE INSTEAD, A FIRSTPASS MINI. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES, AND NOTHING FELL OFF INSIDE THE PATIENT'S ANATOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22353141 ↗
• MalfunctionMay 15, 2025Break; Break

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, THE NOVOSTITCH PRO MEN THE NEEDLE TIP BROKE OFF WHILE ATTEMPTING TO PASS THE SUTURE, THE BROKEN PIECES WERE REMOVED USING ARTHROSCOPIC INSTRUMENTS. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22026988 ↗
• MalfunctionApr 1, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, WHEN MANEUVERING THE NOVOSTITCH INTO THE JOINT, THE SURGEON PULLED ON THE ORANGE HANDLE TO FLATTEN THE TOP JAW, IT MADE A CRACKING NOISE AND THE JAW HINGE HAD BROKEN. THERE WERE NO PIECES THAT FELL OFF OF THE DEVICE, BOTH ENDS REMAINED ATTACHED. 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 21749197 ↗
• MalfunctionFeb 13, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE UPPER JAW JOINT OF THE NOVOSTITCH BROKE DURING THE OPERATION. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. THERE WAS A BACK-UP DEVICE AVAILABLE. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21375968 ↗
• MalfunctionNov 27, 2024Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, A SMALL METAL PIECE OF THE NOVOSTITCH BROKE OFF. ALL THE PIECES WERE REMOVED WITH A GRASPER AND A SHAVER. THE PROCEDURE WAS COMPLETED USING A 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 20797197 ↗
• MalfunctionOct 17, 2024Break; Break

  IT WAS REPORTED THAT, DURING A MENISCAL REPAIR, THE NOVOSTITCH WAS COMING OUT OF THE JOINT AND HIT THE CONDYLE SLIGHTLY, A SMALL PIECE ABOVE THE UPPER JAW BROKE AND A METAL PART SEEMED TO POP OUT. ALSO, THERE WAS A PIECE THAT LOOKED LIKE THE METAL PART STICKING UP, THAT GOT LOST OUTSIDE OF THE KNEE. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20477374 ↗
• MalfunctionAug 26, 2024Mechanical Jam; Firing Problem; Mechanical Jam; Firing Problem

  IT WAS REPORTED THAT DURING A PROCEDURE THE THE FIRST CARTRIDGE NEEDLE COULD NOT PASS THROUGH AND JAMMED IN THE SOFT TISSUE, NOVOSTITCH FAILED TO FIRE, RADIO FREQUENCY WAS REQUIRED TO RELEASE THE SOFT TISSUE AND TOOK OUT THE NOVOSTITCH SYSTEM. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS A SURGICAL DELAY OF 1-30MIN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20064058 ↗
• MalfunctionApr 3, 2024Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROPLASTY, THE NEEDLE OF THE NOVOSTITCH WAS BROKEN. THE DEVICE BROKE INSIDE THE PATIENT BUT ALL PIECES WERE REMOVED USING FORCEPS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 3 MINUTE DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19036397 ↗
• MalfunctionFeb 14, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL, IT WAS NOTICED THAT THE JAW OF A NOVOSTITCH WAS BROKEN AND A PIECE OF METAL COULD BE OBSERVED IN THE JOINT; WHICH WAS REMOVED. SURGERY RESUMED AFTER A SURGICAL DELAY GREATER THAN 30 MINUTES WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18703379 ↗
• MalfunctionFeb 13, 2024Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE NOVOSTITCH JAW HINGE BROKE OFF IN PATIENT, A SMALL HOOK OF HINGE WAS SNAPPED OFF AND RETRIEVED FROM PATIENT USING ARTHROSCOPIC GRASPERS. X RAY WAS USED TO ENSURE NO OTHER PIECES WERE LEFT INSIDE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DELAY GREATER THAN 30 MINUTES USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT IS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18695797 ↗
• MalfunctionJan 25, 2024Break; Difficult to Open or Close; Break; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPY, THE JAW ON THE NOVOSTITCH WAS BROKEN AND WAS UNABLE TO BE LIFTED BEFORE THE SECOND STITCH TO PASS THROUGH THE MENISCUS. THE PROCEDURE WAS COMPLETED WITH A S+N 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 18581454 ↗
• MalfunctionDec 26, 2023Break; Flaked; Break; Flaked

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, TWO (2) NOVOSTITCH PRO BROKE AND A SMALL PIECE OF METAL BROKE OFF INTO THE PATIENT JOINT BOTH TIMES. THE PIECES WERE REMOVED. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18394857 ↗
• MalfunctionNov 24, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING ARTHROSCOPY, THE NOVOSTITCH HAD AN UNSPECIFIED FAILURE. THE PROCEDURE WAS CANCELED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18204667 ↗
• MalfunctionOct 4, 2023Break; Break

  IT WAS REPORTED THAT DURING SET UP, WHEN THE NOVOSTITCH PRO´S ORANGE LEVER WAS PULLED, THE TOP JAW OF THE DEVICE DID NOT MOVE. NO DELAY WAS REPORTED AND THERE WAS A SMITH AND NEPHEW BACK UP DEVICE AVAILABLE. THERE WAS NO PATIENT INVOLVEMENT. RESULTS OF INVESTIGATION FOUND THAT THE INSERTION DEVICE WAS RETURNED WITH A BROKEN ARTICULATION BAR ON THE UPPER JAW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17871265 ↗
• MalfunctionOct 4, 2023Break; Failure to Fire; Break; Failure to Fire

  IT WAS REPORTED THAT, DURING A MENISCAL REPAIR, THE JAW OF THE NOVOSTITCH COULD NOT BE FIRED. SURGERY WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY, USING A BACK-UP DEVICE INSTEAD. NO FURTHER COMPLICATIONS WERE REPORTED. UPON INVESTIGATION, IT WAS FOUND THAT THE NOVOSTICH WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17870416 ↗
• MalfunctionOct 4, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR SURGERY THE NOVOSTITCH'S JAWS, BOTH UPPER AND LOWER, WERE STUCK TOGETHER, AND IT WAS UNABLE TO OPEN IT. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. AS PER INVESTIGATION RESULTS, THE ARTICULATING BAR ON THE TOP DEVICE JAW WAS FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17868666 ↗
• MalfunctionSep 25, 2023Break; Break

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, THE NOVOSTITCH DEVICE FAILED. WHEN THE DOCTOR MANIPULATED THE DEVICE'S UPPER PADDLE INSIDE THE PATIENT'S CAVITY, THE DEVICES BROKE AND OFTEN STOPPED RESPONDING TO THE MOVEMENT. NO BROKEN PIECE FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT STATUS IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17814822 ↗
• MalfunctionSep 25, 2023Break; Break

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, THE NOVOSTITCH DEVICE FAILED. WHEN THE DOCTOR MANIPULATED THE DEVICE'S UPPER PADDLE INSIDE THE PATIENT'S CAVITY, THE DEVICES BROKE AND OFTEN STOPPED RESPONDING TO THE MOVEMENT. NO BROKEN PIECE FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT STATUS IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17814821 ↗