OPTIFIX 0113127Recalls & reported problems

Summary

The FDA's MAUDE database contains 118 adverse event reports that list this exact device (DI 00801741074325), received between Dec 27, 2018 and Sep 23, 2026 — classified as 1 injury, 117 malfunctions.

The most frequently reported specific device problem is “Break” (74 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 118 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873032 ↗
• MalfunctionAug 20, 2026Failure to Form Staple

  As reported on 28-Jul-2026, during a laparoscopic left inguinal hernia repair halfway through the use of the OptiFix fixation device, it did not "fully tack the mesh down, when the resident was attempting to use it." "The surgeon took over and after a few more failed attempts, when pulling the trigger, there was a jam and it did not release anything." The procedure was completed with another device. There was no patient harm or injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50346384 ↗
• MalfunctionAug 13, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50237927 ↗
• MalfunctionJun 29, 2026Failure to Form Staple

  AS REPORTED, DURING A TAPP PROCEDURE, THE HEALTH PROFESSIONAL ATTEMPTED TO SECURE THE MESH USING OPTIFIX STRAIGHT FIXATION DEVICE; HOWEVER, THREE (3) CONSECUTIVE FASTENERS FAILED TO PENETRATE THE TISSUE AND FELL OUT. REPORTEDLY, THE FASTENERS WERE DEPLOYED INTO THE LIGAMENT AREA, AND THE LOOSE FASTENERS WERE SUBSEQUENTLY REMOVED FROM THE PATIENT'S BODY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25653272 ↗
• MalfunctionJun 11, 2026Failure to Form Staple; Material Twisted/Bent

  AS REPORTED, DURING THE PROCEDURE WHILE STAPLING IN THE COOPER'S LIGAMENT USING OPTIFIX STRAIGHT FIXATION DEVICE, THE STAPLER APPARENTLY SLIPPED, CAUSING THE PILOT TIP (GUIDEWIRE) TO BEND, WHICH PREVENTED SUBSEQUENT STAPLES FROM BEING EJECTED. REPORTEDLY, TWO STAPLES COULD BE PLACED ON EITHER SIDE OF THE INFERIOR ABDOMINAL WALL ARTERIES AND VEINS, AND ONE ON THE INNER SIDE. THE LOOSE AND BROKEN FASTENERS WERE REMOVED FROM PATIENT'S BODY. THE SURGEON WAS THE FIRST-TIME USER OF THE DEVICE AND DRY FRIED THE DEVICE TO CHECK THE PROBLEM RE-OCCURRENCE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25472374 ↗
• MalfunctionMay 27, 2026Break

  AS REPORTED, DURING THE PROCEDURE USING THE OPTIFIX ABSORBABLE FIXATION DEVICE, IT WAS OBSERVED THAT THE FASTENERS FAILED TO FIXATE AND BROKE ON THE FIRST FIRE. REPORTEDLY, THE FIRST FIXATION DEVICE IS DAMAGED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25304390 ↗
• MalfunctionApr 16, 2026Failure to Form Staple

  AS REPORTED, DURING A LAPAROSCOPIC INCISIONAL HERNIA REPAIR THE OPTIFIX FIXATION DEVICE FAILED TO SECURE THE MESH AND THE FASTENERS WERE OBSERVED TO FALL OUT. THE SURGEON ATTEMPTED SEVERAL TIMES BUT FAILED TO FIXATE SUCCESSFULLY. ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24896734 ↗
• MalfunctionApr 9, 2026Failure to Form Staple

  AS REPORTED, DURING REPAIR OF AN ABDOMINAL WALL INCISIONAL HERNIA PROCEDURE, THE OPTIFIX FASTENERS FAILED TO FIXATE THE MESH, AND SLIPPED INTO THE ABDOMINAL CAVITY. THE LOOSE FASTENERS WERE RETRIEVED FROM THE PATIENT'S BODY. REPORTEDLY, FIVE TO SIX ATTEMPTS WERE MADE BUT NONE GOT FIXATED. IT WAS ALSO REPORTED THAT INITIALLY ANOTHER PRODUCT WAS USED FOR FIXATION AND FOR ADDITIONAL FIXATION THE ALLEGED DEVICE WAS USED. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24830210 ↗
• MalfunctionFeb 26, 2026Detachment of Device or Device Component

  AS REPORTED, ON (B)(6) 2026, AN UNUSUAL RATTLING SOUND CAME FROM THE OPTIFIX STRAIGHT DEVICE AFTER OPENING THE PRODUCT, "IT SOUNDED LIKE A PART HAD COME LOOSE" PER INFORMATION REPORTED, THE ISSUE WAS IDENTIFIED IMMEDIATELY AFTER OPENING, SO NO ACTUATION OF THE HANDLE WAS PERFORMED. A NEW PRODUCT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24456397 ↗
• MalfunctionFeb 26, 2026Break

  AS REPORTED, DURING A PROCEDURE ON (B)(6) 2026, THE OPTIFIX STRAIGHT FIXATION DEVICE MALFUNCTIONED, AND NO FASTENERS GOT FIRED; THEY WERE DAMAGED. REPORTEDLY, THE BROKEN FASTENERS WERE COLLECTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24456018 ↗
• MalfunctionDec 23, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED, DURING A TAPP PROCEDURE, THE OPTIFIX STRAIGHT FIXATION DEVICE FIRED ITS FIRST FASTENER AT AN OBLIQUE ANGLE INSTEAD OF STRAIGHT AS INTENDED. THE PROCEDURE WAS THEN COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878007 ↗
• MalfunctionDec 15, 2025Break; Break

  AS REPORTED, ON (B)(6) 2025 DURING A PROCEDURE OPTIFIX FIXATION DEVICE WAS USED TO SECURE THE 3DMAX LIGHT MESH. IT WAS REPORTED THAT THE FASTENER BROKE WHILE FIXATING THE 3DMAX LIGHT MESH IN TO THE PUBIC BONE AREA AND THE BROKEN FASTENERS WERE REMOVED FROM THE PATIENT'S BODY. THE DEVICE FAILED TO FIRE DURING DRY FIRING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23802873 ↗
• MalfunctionDec 8, 2025Break; Break

  AS REPORTED, ON (B)(6) 2025 DURING A PROCEDURE THE OPTIFIX FIRST FASTENER BROKE AND CAME OUT. DESPITE THE MALFUNCTION, THREE FASTENERS WERE SUCCESSFULLY FIXATED. THE FIXATION WAS SECURED ADEQUATELY, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23741877 ↗
• MalfunctionNov 10, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED, A LAPAROSCOPIC INGUINAL HERNIA REPAIR SURGERY WAS PERFORMED USING OPTIFIX STRAIGHT FIXATION DEVICE. IT WAS REPORTED THAT DURING THE PROCEDURE, FASTENER BROKE AND THE BROKEN FASTENER WAS REMOVED FROM THE PATIENT'S BODY. SUBSEQUENTLY, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23510076 ↗
• MalfunctionJan 31, 2025Break; Break

  AS REPORTED, DURING LAPAROSCOPIC INGUINAL HERNIA REPAIR PROCEDURE, THE SURGEON TRIED TO FIXATE THE 3DMAX LIGHT MESH USING OPTIFIX FIXATION DEVICE. IT WAS REPORTED THAT THE DEVICE DEPLOYED BROKEN FASTENER WHERE IT WAS FIXED TO THE PUBIC BONE ON BOTH SIDES OF THE INTERNAL INGUINAL HERNIA AND IT WAS REMOVED FROM PATIENT'S BODY. IT WAS REPORTED THAT THREE FASTENERS WERE SUCCESSFULLY RELEASED FROM THE DEVICE AND NONE OF THEM WAS FIXATE INTO THE MESH. IT WAS REPORTED THAT THE DEVICE DEPLOYED FASTENER NORMALLY OTHER THAN HARD STRUCTURE AND THE PROCEDURE WAS COMPLETED BY USING ANOTHER COMPANY DEVICE. THERE WAS NO REPORTED PATIENT INJURY. THIS FILE REPRESENTS DEVICE#: 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21284592 ↗
• MalfunctionJan 31, 2025Break; Break

  AS REPORTED, DURING LAPAROSCOPIC INGUINAL HERNIA REPAIR PROCEDURE, THE SURGEON TRIED TO FIXATE THE 3DMAX LIGHT MESH USING OPTIFIX FIXATION DEVICE. IT WAS REPORTED THAT THE DEVICE DEPLOYED BROKEN FASTENER WHERE IT WAS FIXED TO THE PUBIC BONE ON BOTH SIDES OF THE INTERNAL INGUINAL HERNIA AND IT WAS REMOVED FROM PATIENT'S BODY. IT WAS REPORTED THAT THE DEVICE DEPLOYED FASTENER NORMALLY OTHER THAN HARD STRUCTURE AND THE PROCEDURE WAS COMPLETED BY USING ANOTHER COMPANY DEVICE. THERE WAS NO REPORTED PATIENT INJURY. THIS FILE REPRESENTS DEVICE #1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21284583 ↗
• MalfunctionJan 31, 2025Break; Break

  AS REPORTED, DURING A TRANSABDOMINAL PREPERITONEAL (TAPP) PROCEDURE, AFTER FIXATING THE MESH SUCCESSFULLY DURING THE INITIAL 5 SHOTS, THE OPTIFIX DEVICE HANDLE BECAME STIFF ON THE SIXTH SHOT WHILE FIXATING IN COOPER'S LIGAMENT AND THE FASTENER CAME OUT CRACKED. IT WAS REPORTED THAT THE CRACKED (BROKEN) FASTENER WAS REMOVED, AND THE SEVENTH FASTENER DID NOT COME OUT THEREFORE ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21283002 ↗
• MalfunctionJan 17, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED, DURING ONE INGUINAL HERNIA REPAIR PROCEDURE, THE FASTENERS OF OPTIFIX FIXATION DEVICE WERE NOT FIXATING (DEVICE #1, #2 - 15 COUNT, DEVICE #3 - 30 COUNT). IT WAS REPORTED THAT SURGEON WAS AN EXPERIENCED USER OF THE DEVICE BUT HAD ISSUES THIS TIME DURING USE. AS REPORTED, THE AREA OF FIXATION WAS NOT ANY BONE OR LIGAMENT AND THE FASTENERS THAT WERE NOT FIXATING WERE REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21179496 ↗
• MalfunctionJan 17, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED, DURING ONE INGUINAL HERNIA REPAIR PROCEDURE, THE FASTENERS OF OPTIFIX FIXATION DEVICE WERE NOT FIXATING (DEVICE #1, #2 - 15 COUNT, DEVICE #3 - 30 COUNT). IT WAS REPORTED THAT SURGEON WAS AN EXPERIENCED USER OF THE DEVICE BUT HAD ISSUES THIS TIME DURING USE. AS REPORTED, THE AREA OF FIXATION WAS NOT ANY BONE OR LIGAMENT AND THE FASTENERS THAT WERE NOT FIXATING WERE REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21179493 ↗
• MalfunctionJan 3, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, THE OPTIFIX DEVICE WAS USED TO FIXATE THE MESH. IT WAS REPORTED THAT THE FIRST ATTEMPT WAS FIXED AS USUAL BUT THE SECOND TIME THE FASTENER FELL OUT AND AFTER THE THIRD ATTEMPT NO FASTENERS DEPLOYED. IT WAS ALSO REPORTED THAT A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21066587 ↗
• MalfunctionOct 23, 2024Break; Break

  AS REPORTED, DURING A PROCEDURE AN OPTIFIX (DEVICE #1) WAS USED WHICH DEPLOYED BROKEN FASTENERS. IT WAS REPORTED THAT ANOTHER OPTIFIX (DEVICE #2) WAS USED WHICH DEPLOYED SOME BROKEN FASTENERS AS WELL THEREFORE ANOTHER NEW DEVICE WAS OPENED, AND THE PROCEDURE WAS COMPLETED WITHOUT A PROBLEM. THERE WAS NO PATIENT INJURY. THIS FILE REPRESENTS THE OPTIFIX (DEVICE #1).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20514117 ↗
• MalfunctionOct 23, 2024Break; Break

  AS REPORTED, DURING A PROCEDURE AN OPTIFIX (DEVICE #1) WAS USED WHICH DEPLOYED BROKEN FASTENERS. IT WAS REPORTED THAT ANOTHER OPTIFIX (DEVICE #2) WAS USED WHICH DEPLOYED SOME BROKEN FASTENERS AS WELL THEREFORE ANOTHER NEW DEVICE WAS OPENED, AND THE PROCEDURE WAS COMPLETED WITHOUT A PROBLEM. THERE WAS NO PATIENT INJURY. THIS FILE REPRESENTS THE OPTIFIX (DEVICE #2).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20514045 ↗
• MalfunctionJun 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A TAPP PROCEDURE, WHEN GRIPPED THE HANDLE OF THE OPTIFIX FIXATION DEVICE IN ORDER TO FIX THE FASTENER, IT STRUCK, AND THE TIP END POINT CAME OFF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19574598 ↗
• MalfunctionJun 13, 2024Break; Break

  AS REPORTED, DURING A PROCEDURE THERE WAS NO FASTENER HEAD ON THE FIRST TWO FIRES OF OPTIFIX STRAIGHT FIXATION DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19531755 ↗
• MalfunctionJun 7, 2024Failure to Form Staple; Failure to Form Staple

  AS REPORTED, DURING A PROCEDURE, THE OPTIFIX STRAIGHT FIXATION DEVICE IS "NOT FIXATING THE MESH DUE TO EMPTY HITTING AND POOR EJECTION". THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19491371 ↗