TRIGEN 71631140Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 03596010419644), received between Jul 17, 2020 and Apr 1, 2026 — classified as 8 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (12 reports).

1 other recall cover devices cleared under the same FDA submission (K122170); they may or may not involve this specific model.

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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2026Break

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, WHEN ATTEMPTING TO REMOVE THE DRILL GUIDE HANDLE FROM THE INTERTAN 11.5MM X 18CM 125D, THE TIP OF A GUIDE BOLT WRENCH BROKE OFF INSIDE THE DRILL GUIDE HANDLE (CASE-(B)(4). AFTERWARDS, ANOTHER ATTEMPT WAS MADE TO REMOVE THE INTERTAN 11.5MM X 18CM 125D FROM THE DRILL GUIDE HANDLE ON THE BACK TABLE, AND ANOTHER GUIDE BOLT WRENCH BROKE. IT IS UNKNOWN HOW WAS THE PROCEDURE COMPLETED OR IF THERE WAS ANY SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24757004 ↗
• MalfunctionJan 12, 2026Fracture

  IT WAS REPORTED THAT, DURING NAIL PROCEDURE, TWO (2) GUIDE BOLT WRENCH'S SHEARED OFF WHEN TRYING TO REMOVE BOLT FROM NAIL. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24048636 ↗
• MalfunctionMay 19, 2025Fracture; Difficult or Delayed Separation; Fracture; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING SURGERY, THE PERCUTANEOUS GUIDE BOLT CROSS THREADED INTO JIG CAUSING GUIDE BOLT WRENCH HEAD TO BREAK OFF DURING JIG REMOVAL. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE PATIENT. ALSO, IT IS UNKNOWN HOW PROCEDURE WAS FINISHED AND IF THERE WAS ANY DELAY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22045697 ↗
• MalfunctionFeb 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN EXCHANGE OF METATAN LAG AND COMPRESSION SCREWS SURGERY, THE THREADED PORTION OF ONE (1) GUIDE BOLT WRENCH BROKE WITHIN THE SCREW. THE PROCEDURE WAS RESUMED, AFTER NON-SIGNIFICANT DELAY, WITH S+N BACKUP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21314196 ↗
• MalfunctionFeb 1, 2023Break; Break

  IT WAS REPORTED THAT, WHEN ATTEMPTING TO DETACH AN INTERTAN NAIL FROM THE JIG USING ONE (1) GUIDE BOLT WRENCH THE HEAD SNAPPED OFF. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16278127 ↗
• MalfunctionNov 28, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING TRAUMA SURGERY, THE TIP OF ONE (1) GUIDE BOLT WRENCH BROKE OFF IN DRILL GUIDE. THE TIP OF THE GUIDE BOLT WRENCH HAD BROKEN OFF INSIDE OF THE DRILL GUIDE WHILE TAKING THE DRILL GUIDE OFF THE NAIL. THIS CAUSED A DELAY IN THE PROCEDURE WHICH CAUSED THE NAIL TO BE TAKEN OUT AND A NEW ONE PUT IN. THERE WAS A SURGICAL DELAY GREATER THAN 30 MIN. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15875141 ↗
• InjuryNov 28, 2022Fracture; Separation Failure; Fracture; Separation Failure

  IT WAS REPORTED THAT DURING A TRAUMA SURGERY, AT THE MOMENT OF REMOVING THE CLOVE FROM THE ARCH, USING THE GUIDE BOLT WRENCH DEVICE, THE SCREW DID NOT COME OUT OF THE CLOVE AFTER MANY ATTEMPTS, THE SCREWDRIVER BROKE INSIDE THE CLOVE. THE SCREWS WERE REMOVED FROM THE PATIENT'S CLOVE AND AFTER AN HOUR OF TRYING, IT WAS POSSIBLE TO UNSCREW IT AND THE NEW CLOVE WAS PLACED. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A COMPETITOR DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15874923 ↗
• InjuryJun 6, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, WHILE BEING USED TO SECURE AN IM NAIL TO THE JIG, THE END OF A TRIGEN GUIDE BOLT WRENCH SNAPPED OFF OUTSIDE THE PATIENT. THE PART THAT SNAPPED OFF WENT ON THE FLOOR AND THEN A HEALTHCARE PROFESSIONAL WITH BLOOD ON THEIR GLOVES PICKED IT UP, CONTAMINATING THE BROKEN PIECE. SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14610435 ↗
• MalfunctionApr 5, 2022Break; Break

  IT WAS REPORTED THAT A GUIDE BOLT WRENCH BROKE. FURTHER INFORMATION IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 14018446 ↗
• MalfunctionFeb 1, 2022Break; Break

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE GUIDE BOLT WRENCH BROKE OUTSIDE THE PATIENT. NO PIECES FELL INTO PATIENT. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13418032 ↗
• InjuryNov 26, 2021Manufacturing, Packaging or Shipping Problem; Adverse Event Without Identified Device or Use Problem; Manufacturing, Packaging or Shipping Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING SET UP OR INSPECTION, A GUIDE BOLT WRENCH WAS NOT SENT. THE MISSING ITEM WAS NOT COMMUNICATED TO THE HOSPITAL OR THE REPRESENTATIVE BY CUSTOMER SERVICES AND THIS WAS NOT PICKED UP UNTIL THE PATIENT WAS ON THE TABLE. THE PROCEDURE WAS COMPLETED USING A S+N BACK-UP DEVICE. SURGERY WAS DELAYED FOR MORE THAN 30 MINUTES (APPROXIMATELY 1 HOUR). PATIENT WAS UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12878024 ↗
• InjurySep 29, 2021Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT, DURING TRAUMA SURGERY, THE SURGEON WAS UNABLE TO UNSCREW A TRIGEN 7/16 GUIDE BOLT AND REMOVE THE ALIGNMENT DRILL GUIDE. EXCESSIVE FORCE WAS USED TO LOOSEN THE TRIGEN 7/16 GUIDE BOLT, WHICH LED TO BREAKAGE OF A TRIGEN GUIDE BOLT WRENCH. THE TIP OF THE TRIGEN GUIDE BOLT WRENCH GOT STUCK INSIDE THE TRIGEN 7/16 GUIDE BOLT. THE ISSUE WAS SOLVED BY DRILLING A HOLE THROUGH THE TRIGEN 7/16 GUIDE BOLT WITH A METAL BUR. THE ALIGNMENT GUIDE WAS REMOVED WITH A BACK-UP GUIDE BOLT WRENCH. A SIGNIFICANT DELAY WAS CAUSED AS CONSEQUENCE OF THIS PROBLEM. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12551066 ↗
• MalfunctionJul 14, 2021Break; Break

  IT WAS REPORTED THAT DURING A INTERNAL FIXATION SURGERY, A GUIDE BOLT WRENCH WAS BROKEN. THIS HAPPENED WHILE REMOVING THE GUIDE BOLT FROM THE NAIL WITH THE WRENCH AFTER INSERTING A NAIL. THE WRENCH DID NOT ROTATE, SURGEON HIT IT WITH A HAMMER AND THE WRENCH BROKE OFF AT THE CONSTRICTED PART. THE TIP OF THE DEVICE REMAINED INSIDE THE GUIDE BOLT WAS REMOVED. THE INSERTED NAIL AND SCREW WAS REMOVED, THEN THE GUIDE BOLT AND NAIL WERE SEPARATED. THE REMOVED NAIL WAS INSERTED AGAIN. SURGERY WAS RESUME, WITH SMITH AND NEPHEW SURGICAL DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE AND UNKNOWN COMPETITOR DEVICE. IT IS UNKNOWN IF THE PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12168090 ↗
• InjuryApr 21, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TRAUMA SURGERY THE TIP OF THE GUIDE BOLT WRENCH SNAPPED OFF WHILE TRYING TO UNCROSS THREAD FROM THE NAIL. A COMPETITOR DEVICE WAS USED TO COMPLETE THE PROCEDURE, WHICH WAS DELAYED LESS OR EQUAL TO 30 MIN. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11699816 ↗
• MalfunctionApr 18, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING A TRAUMA NAIL INSERTION PROCEDURE, THE END OF A GUIDE BOLT WRENCH IS STRIPPED. INSTRUMENTS WERE OUTSIDE THE PATIENT AND THERE WAS NO DELAY. THERE IS NO INFORMATION REGARDING HOW THE PROCEDURE WAS COMPLETED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683487 ↗
• MalfunctionMar 15, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, UPON INSPECTION, THE GUIDE BOLT WRENCH WAS SEEN TO BE ROUNDED. NO CASE OR PATIENT 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 11479227 ↗
• MalfunctionNov 5, 2020Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS BROKE. IT IS UNKNOWN WHEN THE EVENT OCCURED, IF THERE WAS ANY DELAY, HOW WAS THE PROCEDURE FINISHED AND IF THERE WAS ANY PATIENT INVOLVED IN THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10795997 ↗
• MalfunctionOct 5, 2020Break; Break

  IT WAS REPORTED THAT THE GUIDE BOLT WRENCH WAS FOUND TO BE BROKEN INTO THE TRAY. NO CASE RELATED THEREFORE NO PATIENT INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10632334 ↗
• InjurySep 22, 2020Break; Break

  IT WAS REPORTED THAT WHILE ATTEMPTING TO LOOSEN THE GUIDE BOLD, DURING AN INTERTAN NAIL PROCEDURE, THE TIP OF THE GUIDE BOLT WRENCH BROKE OFF. A DELAY OF MORE THAN 30 MINUTES REPORTED. NO ADDITIONAL PATIENT INJURIES REPORTED. AN S&N BACKUP WAS NOT AVAILABLE AND THE PROCEDURE HAD TO BE COMPLETED WITH A COMPETITOR DEVICE.

  Patient problems: No Code Available

  MAUDE report 10566271 ↗
• InjuryJul 23, 2020Break; Defective Device; Break; Defective Device

  IT WAS REPORTED THAT DURING SURGERY THE INTERTAN NAIL WAS IMPLANTED AND THE PROCEDURE WENT PERFECTLY. AFTER THE LAG AND COMPRESSION SCREWS WERE INSERTED THE SET SCREW WAS ADVANCED. WHEN THE GUIDE BOLT WRENCH WAS APPLIED TO REMOVE THE NAIL FROM THE DRILL GUIDE THE GUIDE BOLT WOULDN'T COME OUT. ADDITIONAL FORCE WAS APPLIED TO THE DRIVER AND IT BROKE INSIDE THE PATIENT, ALL PIECES RECOVERED. THE IMPLANT WAS REMOVED BECAUSE IT COULD NOT BE RELEASE FROM THE DRILL GUIDE BECAUSE THE HEX DRIVER BROKE. THE SURGEON HAD TO USE A COMPETITOR'S DEVICE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. A DELAY GREATER THAN 30 MIN WAS 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 10317527 ↗
• InjuryJul 17, 2020Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT DURING SURGERY, WHILE TRYING TO TAKE THE GUIDE BOLD OUT, ADDITIONAL FORCE WAS APPLIED TO THE DRIVER AND DEVICE BROKE WHILE INSIDE THE PATIENT. ALL PIECES WERE RECOVERED AND A DELAY GREATER THAN 30 MINUTES WAS REPORTED. PROCEDURE CONCLUDED WITHOUT INJURIES AND WITH A BACKUP DEVICE FROM A COMPETITOR.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions; No Information

  MAUDE report 10292683 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122170. One submission often covers many models, so check the product and lot details in each record.

• Z-0351-2020 · Oct 7, 2019 · Terminated
  LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN nails are indicated for fractures of the femur including: simple shaft fractures, comminuted sha