TRIGEN 71674078Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 03596010560742), received between Feb 26, 2019 and Jun 7, 2023 — classified as 3 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Break” (21 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2023Fracture; Fracture

  IT WAS REPORTED, THAT DURING SURGERY, WHILE DRILLING FOR THE LAG SCREW. THE OBTURATOR BROKE TRYING TO KEEP THE GUIDE IN PLACE. PORTION OF INSTRUMENT THAT BROKE WAS NOT INSIDE THE PATIENT. THE 3.2MM T-HANDLE TROCAR WAS USED IN PLACE OF THE OBTURATOR. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, CHANGING THE SURGICAL TECHNIQUE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17084151 ↗
• MalfunctionMay 4, 2022Break; Break

  IT WAS REPORTED THAT, THE OBTURATOR METAL PART BROKE AWAY FROM THE PLASTIC HANDLE. THIS DIDN'T HAPPEN DURING SURGERY, WAS FOUND LIKE THIS IN CPD, NOT PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14279608 ↗
• MalfunctionApr 16, 2022Break; Break

  IT WAS REPORTED THAT, A T-HANDLE HAS BROKEN TABS ((B)(4)), THE RULER HAS BROKEN THREAD ((B)(4)), THE ENTRY PORTAL IS BROKEN AT SHAFT AND HEAD CONNECTION ((B)(4)) AND THE HANDLE OBTURATOR DOES NOT CONNECT AND DISCONNECT PROPERLY ((B)(4)). AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14131671 ↗
• InjuryApr 5, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE OBTURATOR SNAPPED AT THE CONNECTION POINT. SURGERY WAS RESUMED, WITH A BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY AS CONSEQUENCE OF THIS PROBLEM. PATIENT WAS NOT HARMED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14013662 ↗
• MalfunctionApr 4, 2022Break; Material Deformation; Break; Material Deformation

  DURING SURGERY, AN OBTURATOR BROKE. DEVICE INSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING AN S+N BACKUP DEVICE. THE PATIENT WAS NOT HARMED. DURING INVESTIGATION THE VISUAL INSPECTION OF THE OBTURATOR CONFIRMS THE BLACK KNOB BROKE OFF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14002711 ↗
• MalfunctionApr 1, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE OBTURATOR BROKE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS ISSUE. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13975945 ↗
• MalfunctionMar 31, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION, THE OBTURATOR BROKE WHILE OUTSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13961738 ↗
• MalfunctionMar 31, 2022Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE BLACK END OF AN OBTURATOR BROKE OFF OUTSIDE OF THE PATIENT. THE SURGERY WAS FINISHED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13961625 ↗
• MalfunctionMar 1, 2022Break; Break

  IT WAS REPORTED THAT, THE BACK END OF AN OBTURATOR BROKE OFF WHILE PUSHING THE GUIDE PIN THROUGH. SURGERY WAS FINISHED WITH THE SAME DEVICE. THE INCIDENT DID NOT CAUSE A DELAY. NO HARM TO THE PATIENT NOR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13638723 ↗
• MalfunctionFeb 16, 2022Break; Break

  IT WAS REPORTED THAT TWO (2) TRIGEN OBTURATORS ARE BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13543251 ↗
• InjuryDec 7, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN UNKNOWN SURGERY WHILE THE INSTRUMENTS WERE INSIDE THE PATIENT, THE OBTURATOR AND SCREWDRIVER RELEASE HANDLE WERE BROKEN, AND A COMPRESSION SCREW HEXDRIVER WAS STUCK IN THEIR LAG OF THE INTERTAN SET. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED AND IF THERE WAS ANY DELAY; HOWEVER, PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12953423 ↗
• MalfunctionNov 17, 2021Break; Break

  IT WAS REPORTED THAT, A OBTURATOR BROKE DURING WASH. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12833371 ↗
• MalfunctionNov 17, 2021Fracture; Fracture

  IT WAS REPORTED THAT, A OBTURATOR HAS SNAPPED WHERE METAL MEETS THE HANDLE. AS THIS WAS NOTICED AFTER SURGERY, THE PATIENT WAS NO LONGER INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12831672 ↗
• MalfunctionSep 1, 2021Break; Break

  IT WAS REPORTED THAT, DURING TRAUMA SURGERY WHILE PERFORMING NAIL PROCEDURE, A TRIGEN OBTURATOR BROKE OUTSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM. NO PIECES FELL INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12407675 ↗
• MalfunctionJun 22, 2021Break; Break

  IT WAS REPORTED THAT ON JUNE 6TH DURING AN INTERNAL FIXATION PROCEDURE, THE HEAD OF AN OBTURATOR BROKE OFF WHEN TRYING TO KEEP A GUIDE PIN FROM BACKING OUT DURING NAIL CASE. NO PIECES FELL INTO THE PATIENT, NO INJURY OR SURGICAL DELAY REPORTED. THE PROCEDURE WAS COMPLETED USING A SN BACK UP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12042996 ↗
• MalfunctionJun 22, 2021Break; Break

  IT WAS REPORTED THAT, THE OBTURATOR BROKE INTO TWO PIECES. AS THIS WAS NOTICED DURING STERILIZATION ACTIVITIES, NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12042943 ↗
• MalfunctionFeb 24, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A THR PROCEDURE, THE TIP OF THE OBTURATOR BROKE. NO DELAY OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11376787 ↗
• MalfunctionDec 24, 2020Break; Break

  IT WAS REPORTED THAT, THE OBTURATOR OF A TRIGEN TRAY BROKE. IT IS UNKNOWN WHEN THE EVENT HAPPENED OR IF A PATIENT WAS INVOLVED. 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 11072331 ↗
• MalfunctionNov 24, 2020Break; Break

  IT WAS REPORTED THAT DURING INSPECTION IT WAS NOTICED THAT THE OBTURATOR BROKE. THIS HAPPENED OUTSIDE PATIENT. NO DELAY OR INJURY REPORTED. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACKUP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10891037 ↗
• MalfunctionSep 20, 2020Break; Break

  IT WAS REPORTED THAT THE PLASTIC PART OF THE OBTURATOR BROKE OFF FROM THE METAL SHAFT. IT IS UNKNOWN IF THE EVENT HAPPENED DURING SURGERY OR UPON INSPECTION. IT IS UNKNOWN IF THERE WAS ANY INJURY OR IF A S&N BACKUP DEVICE WAS AVAILABLE.

  Patient problems: No Information

  MAUDE report 10558272 ↗
• MalfunctionAug 26, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE BLACK END OF THE OBTURATOR BROKE OFF, EXTERNAL TO PATIENT, WHEN PUSHING ON THE BALL TIP GUIDE ROD; IT WAS A VERY HARD BONE. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK UP DEVICE, WITH NO SURGICAL DELAY AND NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10453484 ↗
• InjuryJun 29, 2020Mechanical Problem; Defective Device; Mechanical Problem; Defective Device

  IT WAS REPORTED THAT DURING SURGERY IN A NAIL INSERTION. THE SURGEON GAVE IT A COUPLE OF TAPS WITH THE MALLET TO KEEP THE GUIDE PIN FROM BACKING OUT AND THE HEAD OF OBTURATOR CAME APART FROM SHAFT. IT DID NOT CAUSE A DELAY AND IT WAS A NON ISSUE. THE PROCEDURE WAS FINISHED WITH THE SAME 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 10209021 ↗
• MalfunctionJun 26, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE BLACK END OF THE OBTURATOR HAS SHEARED OFF. THERE WAS NO DELAY AND A BACKUP DEVICE WAS AVAILABLE. DEVICE BROKE WHILE IT WAS BEING USED BUT NO PIECE LEFT INSIDE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8735749 ↗
• MalfunctionApr 1, 2019Material Separation; Material Separation

  ITEM BROKE DURING SURGERY AND THE PLASTIC KNOB FELL OFF. NO BROKEN PIECE FELL INTO OR WAS LEFT IN THE PATIENT. NO HARM TO THE PATIENT AND NO DELAY WAS RECORDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8470428 ↗
• MalfunctionFeb 26, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE OBTURATOR KNOB BROKE OFF ON USE. NO DELAY OR INJURY REPORTED. AN AVAILABLE BACK UP DEVICE WAS UNSPECIFIED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8372175 ↗