TRIGEN 71674532Recalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 00885556389348), received between Apr 15, 2019 and May 15, 2026 — classified as 6 injuries, 69 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (17 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 25 most recent of 75 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Fracture

  IT WAS REPORTED THAT, DURING AN INTERTAN SURGERY, ONE (1) INTERTAN 3.2MM GUIIDE PIN SLEEVE BROKE AND ALL PIECES WERE ACCOUNTED FOR. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25184058 ↗
• MalfunctionApr 7, 2026Fracture; Mechanical Jam

  IT WAS REPORTED THAT, DURING A NAILING SURGERY, ONE (1) INTERTAN 3.2MM GUIIDE PIN SLEEVE BROKE. THERE WAS NO SURGICAL DELAY, HOWEVER, IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800306 ↗
• MalfunctionDec 8, 2025Flaked; Difficult to Insert; Flaked; Difficult to Insert

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY ONE INTERTAN 3.2MM GUIIDE PIN SLEEVE HAD DIFFICULTY SLIDING INTO THE LAG SCREW DRILL SLEEVE. DEBRIS CAME OUT AND SURGEON DEEMED IT NOT SAFE TO USE. THE PROCEDURE WAS RESUMED, USING A STRYKER DEVICE. IT IS UNKNOWN IF THIS CAUSED ANY DELAY; HOWEVER, NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23751454 ↗
• MalfunctionOct 23, 2025Failure to Align; Failure to Align

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, WHILE BEING USED IN SCLEROTIC BONE ONE (1) INTERTAN 3.2MM GUIIDE PIN SLEEVE AND ONE (1) LAG SCREW DRILL SLEEVE WERE DIVERGING. AS THE COMPRESSION SCREW DRILL AND ANTI ROTATION BAR CAME THROUGH THE GUIDE AND INTO THE BONE, THEY WERE SHIFTING DOWN AWAY FROM THE PIN THAT WAS ALREADY IN THE HEAD. SWITCHED OUT THE GUIDES AND CASE WENT WELL. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23367083 ↗
• MalfunctionAug 12, 2024Fracture; Material Fragmentation; Detachment of Device or Device Component; Fracture; Material Fragmentation; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE LOCKING BUTTON ON THE INTERTAN 3.2MM GUIDE PIN SLEEVE HAD BROKEN OFF. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19961862 ↗
• MalfunctionJul 19, 2022Fracture; Fracture

  IT WAS REPORTED THAT, THE POINTED TIPS OF AN INTERTAN 3.2MM GUIDE PIN SLEEVE HAVE SNAPPED AWAY. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15055716 ↗
• MalfunctionApr 19, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, (2) INTERTAN 3.2MM GUIDE PIN SLEEVES HAD SOME ISSUES, ONE HAS LOST THE BALL BEARING SO THE INSTRUMENT FALLS OUT AND THE OTHER ONE HAS A STUCK BALL BEARING SO THE INSTRUMENTS DON'T GO TOGETHER. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14140729 ↗
• MalfunctionMar 10, 2022Break; Break

  IT WAS REPORTED THAT, DURING SET UP FOR SURGERY, IT WAS NOTICED THAT THE INTERTAN 3.2MM GUIIDE PIN SLEEVE WAS MISSING THE BUTTON TO CLICK INTO THE DRILL GUIDE SLEEVE. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAY. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13722688 ↗
• MalfunctionJan 26, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING TRAUMA SURGERY. THE INTERTAN 3.2MM GUIIDE PIN SLEEVE WAS DAMAGED WHEN IT BECAME STUCK IN THE SLEEVE. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITH A DELAY GREATER THAN 30 MINUTES. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13353392 ↗
• MalfunctionJan 13, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT A TRIGEN 3.2MM GUIDE PIN SLEEVE IS STRIPPED AND BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13252273 ↗
• MalfunctionJan 3, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING SURGERY THE INTERTAN 3.2MM GUIIDE PIN SLEEVE WAS NOT TARGETING CORRECTLY. THE PROCEDURE WAS COMPLETED, WITH A NON SIGNIFICANT DELAY, USING A S+N BACK UP DEVICE. PATIENT WAS NOT HARMED BEYOND THE PROBLEM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13145150 ↗
• MalfunctionDec 23, 2021Break; Break

  IT WAS REPORTED THAT DURING A INTERNAL FIXATION SURGERY, THE GUIDE PIN OF A INTERTAN 3.2MM GUIIDE PIN SLEEVE BROKE. 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 13078431 ↗
• MalfunctionDec 9, 2021Failure to Align; Failure to Align

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE INTERTAN 3.2MM GUIDE PIN SLEEVE, 125 RAD DRILL GDE DROP, 130 RAD DRILL GDE DROP, DRILL GUIDE HANDLE WOULD NOT TARGET PROPERLY. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICES. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12967034 ↗
• MalfunctionOct 11, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, AN INTERTAN 3.2MM GUIDE PIN SLEEVE BROKE. INCIDENT OCCURRED WITH INSTRUMENT OUTSIDE THE PATIENT, AND NO PIECES FELL INSIDE THE WOUND. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12606284 ↗
• MalfunctionSep 28, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, AN INTERTAN 3.2MM GUIDE PIN SLEEVE BROKE, NO PIECES FELL INSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12544870 ↗
• MalfunctionSep 15, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION, AN INTERTAN 3.2MM GUIDE PIN SLEEVE WOULD NOT SLIDE IN INTERTAN SLEEVE. SURGERY WAS COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MIN, USING A SMITH AND NEPHEW BACK UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12472142 ↗
• InjuryJul 29, 2021Flaked; Flaked

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, SOME METAL SHEARING WAS NOTICED FORM THE TIP OF AN INTERTAN 3.2MM GUIIDE PIN SLEEVE (CASE (B)(4)) WHILE PRESSING DOWN ON IT. THIS WAS NOTICED INTRAOPERATIVELY. NO SIGNIFICANT SURGICAL DELAY OCCURRED, AND THE PROCEDURE WAS CONTINUED WITH A SMITH AND NEPHEW BACKUP DEVICE. NO PATIENT INJURY WAS REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12250784 ↗
• MalfunctionJul 29, 2021Break; Break

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY A INTERTAN 3.2MM GUIDE PIN SLEEVE WAS BROKEN. SURGERY WAS FINISHED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12250209 ↗
• MalfunctionJul 9, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, AN INTERTAN 3.2MM GUIIDE PIN SLEEVE COULD NOT FIT. THIS HAPPENED BEFORE USE IN PATIENT. IT IS UNKNOWN IF THIS CAUSED ANY DELAY AND WAS RESUMED WITH THE SAME OR A BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12143957 ↗
• MalfunctionJun 8, 2021Fitting Problem; Incomplete or Inadequate Connection; Fitting Problem; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE INTERTAN 3.2MM GUIIDE PIN SLEEVE FELL ON THE FLOOR ON THE OPERATION ROOM AND IS DAMAGED, IT WILL NOT FIT INTO THE LAG AND COMPRESSION SLEEVE NOW. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. NO INJURY TO PATIENT OR DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11963005 ↗
• MalfunctionJun 4, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TRAUMA SURGERY, THE INTERTAN 3.2MM GUIIDE PIN SLEEVE WAS BROKEN AND WILL NOT FIT INTO THE DRILL SLEEVE ANYMORE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11936676 ↗
• MalfunctionJun 1, 2021Break; Break

  IT WAS REPORTED THAT, INTERTAN 3.2MM GUIIDE PIN SLEEVE BROKE. IT IS UNKNOWN IF THE EVENT HAPPENED DURING SURGERY OR IF THERE WAS ANY DELAY NOR INJURY REPORTED. IT IS UNKNOWN IF THERE WAS A S&N BACKUP DEVICE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11916951 ↗
• MalfunctionJun 1, 2021Break; Break

  IT WAS REPORTED THAT, INTERTAN 3.2MM GUIIDE PIN SLEEVE BROKE. IT IS UNKNOWN IF THE EVENT HAPPENED DURING SURGERY OR IF THERE WAS ANY DELAY NOR INJURY REPORTED. IT IS UNKNOWN IF THERE WAS A S&N BACKUP DEVICE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11916928 ↗
• MalfunctionMay 31, 2021Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE INTERTAN 3.2MM GUIDE PIN SLEEVE AND THE LAG SCREW DRILL SLEEVE WERE BENT AND HAD TO BE REMOVED FROM EACH OTHER WITH A MALLET. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11909155 ↗
• MalfunctionMay 28, 2021Break; Break

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE INTERTAN 3.2MM GUIDE PIN SLEEVE BROKE OUTSIDE OF THE PATIENT. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED. 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 11904473 ↗

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