NOVOSTITCH CTX-A004Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00853541006051), received between Nov 29, 2018 and Mar 26, 2025 — classified as 11 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC PROCEDURE, THE NOVOSTITCH JAW WAS NOT OPENING AND CLOSING PROPERLY, AND IT WAS LATER DISCOVERED THAT PART OF THE JAW HAD BROKEN OFF INSIDE THE PATIENT. THE SMALL PIECE WAS FLUSHED OUT OF THE JOINT. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE, RESULTING IN A SURGICAL DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21694823 ↗
• MalfunctionNov 11, 2024Break; Firing Problem; Break; Firing Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE NOVOSTICTH PRO DID NOT FIRE CORRECTLY, THERE WAS NO NEEDLE COMING OUT. 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 20660321 ↗
• MalfunctionSep 5, 2024Break; Firing Problem; Break; Firing Problem

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE NOVOSTITCH COULD NOT FIRE PROPERLY. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF APPROXIMATELY 2 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20152770 ↗
• MalfunctionJun 28, 2024Break; Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, A PIECE FROM THE NOVOSTITCH PRO MENISCAL REPAIR SYSTEM BROKE OFF IN THE PATIENT. THE SURGEON ATTEMPTED TO MANUALLY REMOVE THE PIECE WITH ARTHROSCOPIC INSTRUMENTS BUT WAS UNABLE TO. AFTER SEVERAL MINUTES ATTEMPTING TO LOCATE THE PIECE, THE SURGEON ASSUMED IT WAS SUCKED OUT VIA NEPTUNE SUCTION. X-RAY WAS ORDERED AND COMPLETED, AND THE SURGEON CONFIRMED THAT THE IMAGING DID NOT SHOW THE BROKEN PIECE BEFORE CLOSURE. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED. FURTHER INFORMATION IS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19640074 ↗
• MalfunctionJun 6, 2024Break; Failure to Advance; Activation Problem; Break; Failure to Advance; Activation Problem

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, AS THE NOVOSTITCH WAS USED IN A TIGHT SPACE, AND THERE WAS TROUBLE DEPLOYING AND PULLING THE DEVICE OUT. SURGERY WAS COMPLETED WITH A CHANGE IN SURGICAL TECHNIQUE INSTEAD. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES. A SMALL METALLIC PIECE WAS EXTRUDED WITH HELP OF MECHANICAL RESECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19478390 ↗
• MalfunctionFeb 26, 2024Fracture; Firing Problem; Fracture; Firing Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, TWO(2) NOVOSTITCH WERE NOT FIRING CORRECTLY. THE PROCEDURE WAS COMPLETED WITH A DELAY GREATER THAN 30 MINUTES USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18777776 ↗
• InjuryAug 1, 2023Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT DURING AN ACL, THE UPPER JAW OF THE NOVOSTITCH WOULD NOT LIFT WHEN THE ORANGE HANDLE WAS SQUEEZED AND AN IMAGE PROVIDED BY THE REPORTER SHOWS A BROKEN DEVICE HINGE. NOTHING FELL INTO THE PATIENT AND NO INTERVENTION WAS NECESSARY DUE TO THIS PROBLEM. HOWEVER, ALTHOUGH THE PROCEDURE WAS COMPLETED WITHOUT ANY SURGICAL DELAY, THE SURGICAL TECHNIQUE WAS CHANGED TO A PARTIAL MENISCECTOMY INSTEAD OF REPAIR. NO FURTHER COMPLICATIONS WERE REPORTED AND THE SURGEON WAS SATISFIED WITH ALTERNATIVE PROCEDURE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17436092 ↗
• MalfunctionMay 22, 2023Break; Break

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION THE NOVOSTICH JAW WAS NOT ABLE TO OPEN AND CLOSE DUE TO BROKEN JOINT. A BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. THERE WAS A NON-SIGNIFICANT SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16973390 ↗
• MalfunctionApr 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, THE UPPER JAW FROM THE NOVOSTITCH MENISCAL REPAIR SYSTEM FRACTURED DURING ADVANCEMENT. THE DEVICE WAS COMPLETELY REMOVED ALONG WITH THE FRACTURED PART, SINCE THE FRACTURED PART WAS STILL ATTACHED TO THE DEVICE. 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 16732923 ↗
• MalfunctionJan 3, 2023Break; Break

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR, THE UPPER JAW OF THE NOVOSTITCH PRO BROKE BUT NOTHING WENT LOOSE, SO NOTHING FELL OFF NOR RETRIEVED FROM THE PATIENT. THE SURGEON SAID NO MORE POWER THAN USUAL WAS USED. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16086142 ↗
• InjuryOct 17, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE UPPER JAW OF THE NOVOSTITCH PRO MENISCAL REPAIR SYSTEM BROKE, THE BROKEN PIECE WAS SUCCESSFULLY REMOVES BY GRASPER. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK-UP DEVICE. THEY WANTED A RESULT WITH TWO LUGGAGE TAG SUTURES BUT NEEDED TO SETTLE WITH ONE PASSING OF EACH SUTURE. NON-SIGNIFICANT SURGICAL DELAY OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15616412 ↗
• MalfunctionSep 24, 2022Break; Break

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR SURGERY, WHEN THE CARTRIDGE WAS REPLACED, THE AXIS THAT MOVES THE UPPER JAW OF THE NOVOSTITCH BROKE INTO PIECES AND COULD NOT BE MANIPULATED. SURGERY WAS RESUMED WITHOUT DELAY, USING A BACK-UP DEVICE INSTEAD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15481502 ↗
• InjuryJul 12, 2022Break; Break

  IT WAS REPORTED THAT, DURING THE LM LONGITUDINAL TEAR SUTURE PROCEDURE, THE NOVOSTITCH AXIS FOR MOVING THE UPPER JAW BROKE INSIDE THE PATIENT BODY, SO THE JAW COULD NOT BE MANIPULATED. A METAL PIECE OF THE DEVICE FELL INSIDE THE PATIENT BUT IT WAS REMOVED. SURGERY WAS RESUMED, WITHOUT ANY SURGICAL DELAY, WITH A COMPETITOR DEVICE OF STRIKER. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14988242 ↗
• InjuryJul 6, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC PROCEDURE, THE NOVOSTITCH DID NOT WORK AS INTENDED. A PIECE OF METAL OF THE NOVOSTITCH BROKE INSIDE THE PATIENT, BUT IT WAS REMOVED WITH A GRASPER. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT SURGICAL DELAY USING A S+N BACK-UP DEVICE. THE PATIENT'S CURRENT STATUS IS GOOD, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14940560 ↗
• InjuryApr 12, 2022Break; Break

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR, THE AXIS FOR MOVING THE UPPER JAW OF THE NOVOSTITCH FRACTURED IN THE BODY, IT COULD NOT BE MANIPULATED. THE BROKEN PIECE COULD NOT BE REMOVED FROM THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. A NON-SIGNIFICANT DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14089958 ↗
• InjuryMar 24, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE NOVOSTITCH UPPER JAW WAS BROKEN IN THE JOINT; IT COULD NOT PASS THE SUTURE. SURGEON CHECKED THE IMAGE IMMEDIATELY AFTER THE SURGERY; THE BROKEN PIECES COULD NOT BE REMOVED FROM THE PATIENT. TWO LOT NUMBERS WERE PROVIDED, FROM WHICH ONLY 1 HAD THE MALFUNCTION (M210133/M210116) BUT IT IS UNKNOWN WHICH ONE HAD THE REPORTED MALFUNCTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13896528 ↗
• InjuryMar 18, 2022Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT DURING A MENISCAL ROOT REPAIR SURGERY, THE 'NOVOSTITCH PRO MENISCAL REPAIR SYSTEM' WAS USED AND THE FIRST CARTRIDGE FAILED TO PASS THE SUTURE THROUGH THE MENISCUS, BUT THE SECOND CARTRIDGE PASSED SUCCESSFULLY. THE PATIENT RETURNED TO THE CLINIC, THE X-RAYS WERE CHECKED AND A SMALL METAL PART, SIMILAR TO THE TIP OF THE NOVOSTITCH NEEDLE WAS NOTED TO BE IN THE MENISCUS. THE PROCEDURE COMPLETED WITH NO SURGICAL DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13811129 ↗
• InjuryMar 2, 2022Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY, A SMALL PIECE OF THE TIP OF '2-0 NOVOSTITCH' CARTRIDGE BROKE OFF INSIDE THE PATIENTS KNEE. AN EXTRA POSTERIOR LATERAL PORTAL WAS REQUIRED TO REMOVED THE METALLIC PIECE UNDER X-RAYS. THE BROKEN PIECES WERE RETRIEVED WITH AN ARTHROSCOPIC GRASPER. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE. A SIGNIFICANT DELAY GREATER THAN 60MIN TOOK PLACE, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13654700 ↗
• InjuryJan 30, 2022Break; Break

  IT WAS REPORTED THAT, DURING A MENISCAL REPAIR PROCEDURE, THE NOVOSTITCH UPPER JAW WAS BROKEN, IT COULD NOT BE MANIPULATED. THE TIP BROKE INSIDE THE PATIENT, ALL THE PIECES WERE REMOVED. THE PROCEDURE WAS COMPLETED WITHOUT A SIGNIFICANT DELAY. THERE WAS A CHANGE IN THE SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13390426 ↗
• InjuryOct 27, 2021Break; Break

  IT WAS REPORTED THAT, DURING A MENISCAL ROOT REPAIR, THE NOVOSTITCH UPPER JAW WAS BROKEN, IT CANNOT BE MANIPULATED. THE TIP BROKE INSIDE THE PATIENT, ALL THE PIECES WERE REMOVED BUT THE BROKEN PART WAS STILL CONNECTED, NO LOOSE PART WAS FELL OFF. NON SIGNIFICANT DELAY WAS REPORTED, A BACKUP DEVICE WAS AVAILABLE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12707970 ↗
• InjuryFeb 4, 2021Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE UPPER JAW OF THE NOVOSTITCH THAT HOLDS THE WIRE ON THE DEVICE BROKE BEFORE FIRING THE IMPLANTS, WHICH LEADED TO A MALFUNCTION ON THE UPPER JAW. THE PROCEDURE WAS SUCCESSFULLY 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11283710 ↗
• MalfunctionOct 1, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR THE NEEDLE BROKE OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE, AND NO DELAY, OR FURTHER 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 Known Impact Or Consequence To Patient

  MAUDE report 10612428 ↗
• MalfunctionAug 19, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SURGERY, THE PIECE THAT ARTICULATES THE UPPER JAW OF THE NOVOSTITCH MENISCAL REPAIR SYSTEM, BROKE OFF OUTSIDE FROM THE PATIENT'S ANATOMY AFTER THE FIRST CARTRIDGE WAS USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO 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 Known Impact Or Consequence To Patient

  MAUDE report 10427020 ↗
• MalfunctionDec 27, 2018Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  DURING AN ARTHROSCOPIC KNEE SURGERY, ONE SIDE OF THE DEVICE UPPER JAW EAR AND THE DISTAL END OF THE LINK BROKE. THE BREAK COULD HAVE RESULTED FROM JAMMING DEVICE IN AND OUT OF THE KNEE OR INTO STRUCTURES IN KNEE AND/OR EXCESSIVELY TORQUEING THE DEVICE DURING USE. IT WAS REPORTED THAT A SMALL FRAGMENT WAS REMOVED FROM THE PATIENT'S KNEE DURING PRIMARY PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8201142 ↗
• MalfunctionNov 29, 2018Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  DURING AN ARTHROSCOPIC KNEE PROCEDURE, THE UPPER JAW OF THE DEVICE BROKE IN THE PATIENT'S KNEE TWICE. THE PROBABLE CAUSE FOR THE UPPER JAW BREAK COULD BE DUE TO POOR PORTAL PLACEMENT, TIGHT KNEE SPACE, AND/OR APPLICATION OF EXCESSIVE TORQUE BY THE SURGEON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8116013 ↗