TRIGEN 71674041Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 03596010605238), received between May 2, 2019 and Jan 3, 2025 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (11 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2025Break; Break

  IT WAS REPORTED THAT DURING SURGERY, ONE (1) ANTI ROTATION BAR WAS BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21067032 ↗
• MalfunctionOct 2, 2024Break; Break

  IT WAS REPORTED THAT DURING A TRAUMA SURGERY, ONE (1) ANTI ROTATION BAR BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN S+N BACK-UP DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20353155 ↗
• MalfunctionJul 16, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING SURGERY, WHEN INSERTING ONE ANTI ROTATION BAR INTO THE LAG SCREW SLEEVE, IT GOT STUCK, RESULTING IN BOTH THE BAR AND THE GUIDE PIN SLEEVE BEING STUCK INSIDE AND UNABLE TO BE REMOVED. EVERY FORM OF EXTRACTION WAS ATTEMPTED, BUT DUE TO THE POSITION OF THE COMPONENTS, MOVEMENT WAS IMPOSSIBLE. THE PROCEDURE WAS RESUMED AFTER A SIGNIFICANT DELAY. IT IS UNKNOWN HOW THE SURGERY WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19749015 ↗
• MalfunctionJun 29, 2022Break; Break

  IT WAS REPORTED THAT WHEN ASSEMBLING THE SET AFTER CLEANING, THE ANTI ROTATION BAR WAS DISCOVERED TO BE BROKEN. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED. A VISUAL INSPECTION FOUND THAT THE DEVICE WAS BROKEN AT THE DISTAL TIP AND AT THE HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14853585 ↗
• MalfunctionMar 16, 2022Failure to Align; Material Twisted/Bent; Failure to Align; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING TRAUMA CASE, THE ANTI ROTATION BAR WAS BENT AND THEREFORE THROWING OFF ALIGNMENT OF DRILLS AND SCREWS. PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13777939 ↗
• MalfunctionJan 3, 2022Break; Break

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE ANTI ROTATION BAR BROKE OUTSIDE THE PATIENT. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED WITHOUT THE BAR OR A REPLACEMENT. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13142238 ↗
• MalfunctionApr 15, 2021Break; Break

  IT WAS REPORTED THAT, ON A FIELD INSPECTION, THE DRILL GUIDE HANDLE ((B)(4)), AND A CANNULATED IMPACTOR- MED ((B)(4)) HAD DAMAGED THREADS. A RULER ((B)(4)) HAD BROKEN THREADS, A ANTI ROTATION BAR ((B)(4)) HAD BROKEN SHAFT, AND A LAG SCREW DRIVER ((B)(4)) HAD A MISSING SHAFT. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11671379 ↗
• MalfunctionMar 24, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT AFTER PROCEDURE UPON INSPECTION IT WAS NOTICED THAT THE ANTI ROTATION BAR HANDLE IS BENT. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11566429 ↗
• InjuryNov 24, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE ANTI ROTATION BAR BROKE IN HALF AS THE SURGEON WAS INSERTING IT INTO PATIENT DURING HIP FRACTURE INTERTAN CASE. THE PROCEDURE HAD A DELAY OF 5 MINUTE. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACKUP DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10891310 ↗
• MalfunctionSep 23, 2020Break; Break

  IT WAS REPORTED THAT ANTI ROTATION BAR BROKE OUTSIDE THE PATIENT DURING SURGERY. THE PROCEDURE FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. PATIENT INJURIES WERE NOT REPORTED. NO SURGICAL DELAY. 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 10573495 ↗
• InjuryAug 7, 2020Break; Break

  IT WAS REPORTED THAT DURING A TRAUMA PROCEDURE THE ANTI ROTATION BAR GOT CAUGHT AFTER INSERTING THE LAG SCREW, UPON TRYING TO REMOVE THE DEVICE USING A MALLET (THIS IS NOT INDICATED TO BE USED IN THE SURGICAL TECHNIQUE), THE HANDLE BROKE OFF (MECHANICAL FAILURE OF AN INSTRUMENT). NO FRAGMENTS FELL INTO THE PATIENT, THE PART OF THE DEVICE THAT BROKE WAS OUTSIDE OF THE PATIENT AT THE TIME. THIS WAS A TRIGEN INTERTAN PROCEDURE FOR A FEMORAL FRACTURE. ALL PARTS WERE REMOVED AND CASE CONTINUED AND WAS COMPLETED AS NORMAL. A LESS THAN 30 MIN DELAY 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 10382276 ↗
• MalfunctionDec 24, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE HANDLE BROKE OFF THE TOP OF THE ITEM INSIDE THE PATIENT. ANY PIECE FELL INSIDE THE PATIENT. SN BACKUP DEVICE WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9516843 ↗
• MalfunctionNov 28, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY, IN A INTERTAN CASE THE ANTI ROTATION BAR SNAPPED WHILE USING THE LAG SCREW DRILL. DELAY FROM (0-30) MINUTES REPORTED. BACKUP DEVICE AVAILABLE. NO INJURY OR IMPACT TO PATIENT REPORTED.

  Patient problems: No Information

  MAUDE report 9390392 ↗
• MalfunctionMay 2, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY WHEN THE ROTATION BAR WAS BEING REMOVED THE HANDLE SNAPPED OFF. BROKEN PIECES DID NOT GO IN PATIENT, NO INJURY, AND ESTIMATED DELAY WAS 10 MINUTES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8574191 ↗

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