OPTIFIX 0113126Recalls & reported problems

Summary

The FDA's MAUDE database contains 176 adverse event reports that list this exact device (DI 00801741074318), received between Mar 22, 2017 and Sep 4, 2026 — classified as 7 injuries, 169 malfunctions.

The most frequently reported specific device problem is “Break” (86 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 176 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50615626 ↗
• MalfunctionAug 14, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50258084 ↗
• MalfunctionApr 2, 2026Failure to Form Staple

  AS REPORTED, DURING THE BILATERAL LAPAROSCOPIC INGUINAL PLASTY PROCEDURE, THE OPTIFIX FASTENERS CAME OUT SIDEWAYS (CROOKED). THE ISSUE OCCURRED FROM THE FIRST FIRING AND NONE OF THE FASTENERS GOT FIXATED. REPORTEDLY, THERE WERE NO PROTRUDING OR LOOSE FASTENERS PRESENT AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24767366 ↗
• MalfunctionMar 30, 2026Failure to Form Staple

  AS REPORTED, DURING A LAPAROSCOPIC ABDOMINAL WALL SCAR HERNIA REPAIR PROCEDURE, WHILE FIXATING THE VENTRALIGHT ST WITH ECHO 2 MESH, THE OPTIFIX FASTENER FAILED TO COME OUT FROM THE MIDDLE OF THE DEVICE AND THE TIP OF THE DEVICE WAS FOUND TO BE BROKEN. THE SURGEON APPLIED ADEQUATE COUNTER PRESSURE WHILE SECURING THE FASTENERS. IT WAS REPORTED THAT THE FASTENER WAS RETRIEVED FROM THE PATIENT'S BODY, WHICH COULD NOT BE FIXATED. ANOTHER FIXATION DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716132 ↗
• MalfunctionMar 11, 2026Failure to Form Staple

  AS REPORTED, DURING A LAPAROSCOPIC UMBILICAL HERNIA REPAIR, THE FASTENERS DID NOT HOLD AND FELL OFF WHILE THE VENTRALEX MESH WAS BEING FIXATED TO THE ABDOMINAL SOFT TISSUE USING THE OPTIFIX FIXATION DEVICE. IT WAS NOTED THAT THE FIRST THREE FASTENERS WERE FIXATED WITH THE MESH, THE SUBSEQUENT THREE DID NOT FIXATE AND BECAME LOOSE. THE LOOSE FASTENERS WERE REMOVED FROM THE PATIENT'S BODY, RESULTING IN LOSS OF OPERATING TIME. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24567906 ↗
• MalfunctionJan 28, 2026Failure to Form Staple

  AS REPORTED, DURING POST-INCISIONAL HERNIA PROCEDURE USING OPTIFIX STRAIGHT FIXATION DEVICE THE FIRST FOUR FASTENERS FIXATED THE MESH, HOWEVER, THE SUBSEQUENT ONES DID NOT COME OUT WITH ENOUGH FORCE AND THEREFORE DID NOT FIXATE. THE LOOSE FASTENERS WERE REMOVED FROM THE PATIENT'S BODY AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS DISCARDED, AS IT WAS CONTAMINATED WITH BLOOD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24202210 ↗
• InjuryJan 28, 2026Patient-Device Incompatibility

  PER ANSM USER REPORT ((B)(4): IT WAS REPORTED THAT, "SINCE THE INSERTION OF HERNIA REPAIR MESH FOR AN UMBILICAL HERNIA, MY LIFE HAS BEEN HELL, WITH MY HEALTH DETERIORATING, AS CONFIRMED BY A MEDICAL EXAMINATION! MY LIFE IS IN DANGER AND I AM IN INTENSE PAIN, REQUIRING MORPHINE. SINCE THE OPERATION, I HAVE REQUESTED THAT THE MESH BE REMOVED URGENTLY, EVEN IF I HAVE TO GO TO GERMANY TO HAVE IT DONE SINCE THE IMPLANT WAS FITTED, I HAVE BEEN IN AGONY SINCE WAKING UP AFTER THE OPERATION. THE PAIN HAS BEEN DOWNPLAYED BY THE NURSING STAFF, WHO TELL ME I AM EXAGGERATING AND THAT IT IS ALL IN MY HEAD. THE OPERATION SHOULD HAVE BEEN AN OUTPATIENT PROCEDURE, BUT I HAVE BEEN HOSPITALIZED EVER SINCE AND MY LIFE IS NO LONGER THE SAME. COMMENTS: IT IS CRIMINAL TO IMPLANT THIS TYPE OF PROSTHESIS. I AM A CARER AND I WAS NOT SUSPICIOUS ENOUGH. I THOUGHT I COULD TRUST THE SURGEON, BUT THEY STOLE MY LIFE. MY FIVE CHILDREN HAVE LOST THEIR MOTHER, WHO OFTEN HAS TO LIE DOWN BECAUSE OF THE INTOLERABLE PAIN. I AM UNABLE TO SEND YOU THE NECESSARY DOCUMENTS. ERROR DETECTED. PATIENT INFORMATION: CURRENT PATIENT STATUS: SINCE THIS MATERIAL WAS IMPLANTED, I HAVE BEEN SURVIVING. MY GENERAL CONDITION IS DETERIORA

  Patient problems: Depression; Fatigue; Pain

  MAUDE report 24202203 ↗
• MalfunctionJan 12, 2026Break

  AS REPORTED, DURING A PROCEDURE USING OPTIFIX FIXATION DEVICE WHILE DEPLOYING, THE FASTENERS WERE FIRING SIDEWAYS, AND THE FASTENERS HAD BROKEN IN HALF. THE LOOSE FASTENERS WERE REMOVED FROM THE PATIENT'S BODY AND A NEW OPTIFIX DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24041789 ↗
• MalfunctionDec 2, 2025Break; Break

  AS REPORTED, A LAPAROSCOPIC INCISIONAL HERNIA REPAIR WAS PERFORMED ON (B)(6) 2025. DURING THIS PROCEDURE, THE OPTIFIX STRAIGHT FIXATION DEVICE DEPLOYED A BROKEN FASTENER. IT WAS REPORTED THAT THE DEVICE GOT JAMMED WHILE FIRING, AND ONLY A PARTIAL FASTENER WAS DEPLOYED WHEN AN ATTEMPT WAS MADE TO FIXATE AGAIN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A NEW OPTIFIX FIXATION DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694104 ↗
• MalfunctionNov 6, 2025Failure to Form Staple; Material Twisted/Bent; Failure to Form Staple; Material Twisted/Bent

  AS REPORTED, DURING A BILATERAL HERNIA SURGERY, OPTIFIX STRAIGHT FIXATION DEVICE WAS USED TO SECURE THE 3DMAX MESH. IT WAS OBSERVED THAT DURING THE FIRST SHOT, THE DEVICE FAILED TO FIXATE. SUBSEQUENTLY, DURING THE SECOND SHOT, THE FASTENER DID NOT COME OUT OF THE DEVICE. IT WAS REPORTED THAT CORRECT TECHNIQUE OF ANGULATION AND COUNTERPRESSURE WERE USED WHILE FIRING. AFTER THIS FAILURE, WHEN THE SHAFT AND TIP WERE EXAMINED OUTSIDE THE TROCAR, IT WAS NOTED THAT THE ROD INSIDE WHERE THE TACKERS ARE LOADED WAS BENT. IT WAS ALSO REPORTED THAT THE BOX WAS NEITHER CRUSHED NOR DAMAGED. HENCE, A NEW CAPSURE DEVICE WAS USED AS A REPLACEMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23486084 ↗
• MalfunctionOct 31, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED, DURING A PROCEDURE WHILE FIXATING THE MESH TO THE PUBIC SYMPHYSIS, THE OPTIFIX DEVICE FAILED TO FIXATE AND MISFIRED. IT WAS ALSO REPORTED THAT WHILE TRYING TO FIXATE IN THE ANTERIOR ABDOMINAL WALL, THE OPTIFIX DEVICE FAILED TO FIXATE. THERE WAS NO REPORTED PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23436349 ↗
• MalfunctionOct 30, 2025Mechanical Jam; Mechanical Jam

  AS REPORTED, AN INGUINAL HERNIA PROCEDURE WAS PERFORMED ON (B)(6) 2025. DURING THIS PROCEDURE, THE OPTIFIX STRAIGHT FIXATION DEVICE FAILED TO FIRE. IT WAS REPORTED THAT THE DEVICE GOT STUCK WHEN FIRING. WHEN THE DEVICE WAS CHECKED WITH DRY FIRING, IT WAS FOUND TO BE STILL JAMMED. THE PROCEDURE WAS COMPLETED USING A SPARE SORBAFIX FIXATION DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23425734 ↗
• MalfunctionOct 21, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED, A LAPAROSCOPIC BILATERAL INGUINAL HERNIA REPAIR WAS PERFORMED USING THE OPTIFIX STRAIGHT FIXATION DEVICE. DURING THIS PROCEDURE, THE FIRST FASTENER DEPLOYED SUCCESSFULLY. DURING THE DEPLOYMENT OF THE SECOND FASTENER, THE SURGEON FIRED TOO CLOSE TO THE PUBIC BONE, CAUSING THE PILOTING PIN TO BEND, THEREBY FAILED TO TACK PROPERLY. THE FASTENER WAS SUBSEQUENTLY REMOVED FROM THE PATIENT, AND IT WAS SEEN TO BE BROKEN IN HALF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A NEW SORBAFIX DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23347186 ↗
• MalfunctionSep 5, 2025Break; Break

  AS REPORTED, DURING A LAPAROSCOPIC RIGHT INGUINAL SLEEVE PROCEDURE, THE SURGEON ATTEMPTED TO FIX A 3DMAX MESH USING THE OPTIFIX FIXATION DEVICE. DESPITE MULTIPLE ATTEMPTS, THE FASTENERS DID NOT PROPERLY FIXATE AND REMAINED OVERLAPPED ON THE MESH. UPON INSPECTION, THE SURGEON FOUND THAT THE TACKERS WERE BROKEN IN HALF, AND THE LINE WAS MISALIGNED. ALL BROKEN TACKERS WERE REMOVED, AND THE MESH WAS SUCCESSFULLY FIXED USING SUTURES INSTEAD. THE ISSUE OCCURRED DURING INITIAL USE OF OPTIFIX, ALTHOUGH THE SURGEON WAS EXPERIENCED WITH SORBAFIX DEVICE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22976667 ↗
• MalfunctionJul 21, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED, DURING A PROCEDURE OF ATTEMPTING TO FIXATE VENTRALIGHT ST W/ECHO PS, THE TACKERS THAT CAME OUT OF THE TACKER WERE CROOKED AND THEY DIDN'T FIXATE THE MESH PROPERLY. IT WAS REPORTED THAT COUNTER PRESSURE WAS APPLIED TO THE DISTAL END OF THE DEVICE USING CONTRA-LATERAL HAND. NONE OF THE FASTENERS FIXATED THE MESH SUCCESSFULLY AND THOSE WHICH WERE NOT FIXATED WERE REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22557566 ↗
• MalfunctionJun 25, 2025Break; Break

  AS REPORTED, DURING LAPAROSCOPIC SUPRAUMBILICAL REPAIR PROCEDURE, TWO OPTIFIX STRAIGHT FIXATION DEVICE FASTENERS (DEVICE # 1, # 2) WERE DEPLOYED CRUMBLED (BROKEN) WHEN BEING FIXATED NEAR THE SOFT TISSUE. THE PROCEDURE WAS COMPLETED USING ANOTHER OPTIFIX DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22328012 ↗
• MalfunctionJun 25, 2025Break; Break

  AS REPORTED, DURING LAPAROSCOPIC SUPRAUMBILICAL REPAIR PROCEDURE, TWO OPTIFIX STRAIGHT FIXATION DEVICE FASTENERS (DEVICE #1, #2) WERE DEPLOYED CRUMBLED (BROKEN) WHEN BEING FIXATED NEAR THE SOFT TISSUE. THE PROCEDURE WAS COMPLETED USING ANOTHER OPTIFIX DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22327988 ↗
• MalfunctionJun 16, 2025Break; Break

  AS REPORTED, DURING LAPAROSCOPIC AND OPEN REPAIR OF LEFT INGUINAL HERNIA WITH MESH (TAPP) PROCEDURE, THE OPTIFIX DEPLOYED A BROKEN FASTENER WHEN TACKING INTO THE TENDON AREA. IT WAS REPORTED THAT A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY AND PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22211602 ↗
• MalfunctionMar 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING LAPAROSCOPIC HERNIA PLASTY PROCEDURE, THE OPTIFIX STRAIGHT FIXATION DEVICE WAS USED FOR FIXATION. IT WAS REPORTED THAT THE BARREL INSERT WAS DETACHED DURING USE ON THE PATIENT IN THE FIRST ATTEMPT AND THE FASTENERS WERE NOT PROPERLY FIRED. THE FASTENERS FELL STRAIGHT OUT OF THE DEVICE AND NONE OF THE FASTENERS WERE FIXATED CORRECTLY. IT WAS REPORTED THE FASTENERS WERE FIRED TO A HARD STRUCTURE/BONE/COOPER LIGAMENT. THE SURGEON REQUESTED A NEW DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21607505 ↗
• MalfunctionFeb 18, 2025Break; Break

  AS REPORTED, DURING A LAPAROSCOPIC PROCEDURE WHILE FIXING THE MESH IN AN ABDOMINAL DEFECT USING THE OPTIFIX FIXATION DEVICE, ABOUT 4 OR 5 FASTENERS WERE DEPLOYED WITH THE HEAD BROKE OFF FROM THE TIP. IT WAS REPORTED THAT ALL THE BROKEN FASTENERS WERE REMOVED AND THERE WAS NO HARM/INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21396553 ↗
• MalfunctionFeb 7, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED, DURING HERNIA REPAIR PROCEDURE, THE SURGEON TRIED TO FIXATE THE MESH USING OPTIFIX FIXATION DEVICE. THE DEVICE FAILED TO FIXATE THE MESH AT PERITONEUM. IT WAS REPORTED THAT, DUE THE DEVICE ISSUE THERE WAS LONGER SURGICAL AND ANESTHESIA TIME. THERE WAS NO PATIENT INJURY. THIS FILE REPRESENTS DEVICE #1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21339109 ↗
• MalfunctionFeb 7, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED, DURING HERNIA REPAIR PROCEDURE, THE SURGEON TRIED TO FIXATE THE MESH USING OPTIFIX FIXATION DEVICE. THE DEVICE FAILED TO FIXATE THE MESH AT PERITONEUM. IT WAS REPORTED THAT, DUE THE DEVICE ISSUE THERE WAS LONGER SURGICAL AND ANESTHESIA TIME. THERE WAS NO PATIENT INJURY. THIS FILE REPRESENTS DEVICE #2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21339073 ↗
• 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 - (B)(4) COUNT, DEVICE #3 - (B)(4) 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 21179494 ↗
• MalfunctionDec 6, 2024Break; Failure to Form Staple; Break; Failure to Form Staple

  AS REPORTED, DURING A LAPAROSCOPIC HERNIA REPAIR, THE OPTIFIX DEVICE DID NOT FIRE THE FASTENER AT FIRST SHOT, DEPLOYED BROKEN FASTENER DURING THE SECOND FIRE, THE THIRD FASTENER DID NOT FIXATE CORRECTLY, AND SUBSEQUENT FASTENERS GOT STUCK IN DEVICE. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE, NO LOOSE FASTENERS WERE LEFT INSIDE THE BODY, AND NO MEDICAL/SURGICAL INTERVENTION WAS PERFORMED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20863432 ↗
• MalfunctionDec 3, 2024Failure to Form Staple; Failure to Form Staple

  AS REPORTED, DURING A PROCEDURE, THE SURGEON USED AN OPTIFIX FIXATION DEVICE TO FIXATE THE MESH. IT WAS REPORTED THAT WHEN THE DEVICE WAS FIRED, THE FASTENERS SEEMED TO BE STUCK AND UNABLE TO RELEASE SEVERAL FASTENERS. A SORBAFIX DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY. AS PER THE VIDEO PROVIDED, IT CAN BE SEEN THAT A FASTENER DID NOT FIXATE THE MESH/TISSUE, AND THE SURGEON REMOVED THE FASTENER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20836415 ↗