TRIGEN 71674070Recalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 03596010560636), received between Oct 27, 2017 and Apr 8, 2026 — classified as 28 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Fracture” (44 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 25 most recent of 71 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Fracture

  IT WAS REPORTED THAT, DURING A TRAUMA SURGERY, THE TIP OF ONE (1) 7.0 COMPRESSION SCREW DRILL BROKE OFF WHILE IN USE, ALL THE BROKEN PIECES WERE REMOVED AND ACCOUNTED. THE PROCEDURE WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME S+N PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24820851 ↗
• MalfunctionMar 20, 2026Fracture

  IT WAS REPORTED THAT DURING A TRAUMA SURGERY, THE TIP OF THE 7.0 COMPRESSION SCREW DRILL BROKE OFF WHILE IN USE. THE TIP WAS RETRIEVED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY. IT IS UNKNOWN HOW WAS COMPLETED THE SURGERY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24649544 ↗
• MalfunctionMar 18, 2026Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION, THE TIP OF ONE (1) 7.0 COMPRESSION SCREW DRILL BROKE OFF WHILE THE DEVICE WAS IN USE, AND THE TIP WAS RETRIEVED. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED; HOWEVER, THERE WAS A 2-HOUR SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626549 ↗
• MalfunctionFeb 4, 2026Fracture

  IT WAS REPORTED THAT, DURING A FEMUR INTRAMEDULLARY NAILING SURGERY, THE TIP OF ONE (1) 7.0 COMPRESSION SCREW DRILL BROKE WHILE IN USE. THE BROKEN TIP WAS RETRIEVED BUT IT IS UNKNOWN HOW. THE PROCEDURE WAS RESUMED, AFTER A 30 MINUTE DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259323 ↗
• MalfunctionJan 19, 2026Fracture

  IT WAS REPORTED THAT DURING A TRAUMA SURGERY, THE TIP OF ONE (1) 7.0 COMPRESSION SCREW DRILL BROKE WHILE IN USE AND FELL INSIDE PATIENT. THE PIECE WAS RETRIEVED AND ACCOUNTED FOR. THE PROCEDURE WAS COMPLETED AFTER A 20 MINUTES DELAY USING A SIMILAR S+N BACK UP. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24108986 ↗
• MalfunctionNov 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE TIP OF ONE (1) 7.0 COMPRESSION SCREW DRILL BROKE OFF AFTER DRILLING, JUST BEFORE USING THE NEXT DRILL. THE BROKEN TIP WAS RETRIEVED. THE PROCEDURE WAS RESUMED, AFTER A 10 MINUTES DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23451281 ↗
• MalfunctionJun 12, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE TIP OF ONE (1) 7.0 COMPRESSION SCREW DRILL BROKE. THE PIECE WAS RETRIEVED. IT IS UNKNOWN HOW THE PIECE WAS RETRIEVED. THERE IS NOT SURGICAL REPORTS, OPERATIVE NOTES NOR X-RAYS AVAILABLE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT 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 22199839 ↗
• MalfunctionMar 14, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE TIP OF ONE (1) 7.0 COMPRESSION SCREW DRILL WAS BROKEN OFF WHILE IN USE. ALL PIECES WERE RETRIEVED. 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 21606700 ↗
• MalfunctionJan 29, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE TIP OF A 7.0 COMPRESSION SCREW DRILL BROKE OFF WHILE IN USE. PIECES WERE REMOVED FROM THE PATIENT WITH AN UNKNOWN METHOD. THERE WAS A NON-SIGNIFICANT DELAY AND IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21264851 ↗
• MalfunctionJan 6, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TRAUMA SURGERY, THE TIP ON THE INTERTAN 7.0MM COMP SCREW STARTER DRILL BROKE WHILE IN USE. THE PIECE WAS RETRIEVED BUT IT IS UNKNOWN HOW. THERE WAS A NON-SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21080463 ↗
• MalfunctionNov 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING INTERTAN NAIL SURGERY, UPON USING ONE (1) 7.0 COMPRESSION SCREW DRILL, THE TAPERED PART OF THE DRILL, BROKE OFF INSIDE OF THE PATIENT. THE BROKEN PIECE WAS RECOVERED FROM THE PATIENT BY THE SURGEON USING A LONG HEMOSTAT. THE BROKEN TIP WAS DISCARDED BY THE SCRUB NURSE WITH THE REST OF THE SHARPS AT THE END OF THE CASE. 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 20622324 ↗
• MalfunctionSep 27, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TRAUMA SURGERY, THE TIP OF THE 7.0 COMPRESSION SCREW DRILL BROKE OFF AND PIECES FELL INSIDE THE PATIENT'S WOUND, THE BROKEN PIECE WAS RETRIEVED BUT IT IS UNKNOWN HOW. 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 20328119 ↗
• MalfunctionSep 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN ORIF SURGERY, THE TIP OF ONE (1) 7.0 COMPRESSION SCREW DRILL BROKE OFF. THE PIECE WAS RETRIEVED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A S+N BACKUP DEVICE. NO INJURY WAS REPORTED AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20260785 ↗
• MalfunctionJun 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THERE WAS A NOISE WHILE USING THE 7.0 COMPRESSION SCREW DRILL AND IT WAS NOTICED THAT THE TIP HAD BROKEN OFF, THE PIECES WERE RETRIEVED, BUT THE METHOD IS UNKNOWN. THERE WAS A NON-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 19520366 ↗
• MalfunctionJun 11, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TRAUMA, INTERTAN SURGERY, THE TIP ON ONE (1) 7.0 COMPRESSION SCREW DRILL BROKE WHILE IN USE. THE PIECE WAS RETRIEVED. 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 19510551 ↗
• MalfunctionApr 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN ORIF FEMUR PROCEDURE, DRILLING WAS PERFORMED WITH ONE (1) 7.0 COMPRESSION SCREW DRILL. THEN, WHEN DRILLING WITH THE LAG SCREW DRILL, THE DRILL COULD NOT ADVANCE TO THE NAIL DUE TO METAL INTERFERENCE. THE NAIL WAS REMOVED AND CHECKED, AND IT WAS NOTICED THAT THE TIP OF THE COMPRESSION SCREW DRILL HAD FRACTURED AT THE LAG SCREW HOLE. THE BROKEN TIP WAS REMOVED WITH MIKULICZ' FORCEPS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY (10 MIN), WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19154486 ↗
• MalfunctionApr 11, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A INTERNAL FIXATION SURGERY , THE TIP OF ONE (1) 7.0 COMPRESSION SCREW DRILL WAS BROKEN OFF WHILE IN USE AFTER NOISE. THE PIECE WAS RETRIEVED; HOWEVER, IT IS UNKNOWN HOW. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY WITH A SMITH + NEPHEW BACK UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19094032 ↗
• MalfunctionMar 26, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE TIP OF ONE (1) 7.0 COMPRESSION SCREW DRILL BROKE OFF WHILE IN USE. THE PIECE WAS RETRIEVED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 18977092 ↗
• InjuryMar 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION PROCEDURE, THE TIP OF ONE (1) 7.0 COMPRESSION SCREW DRILL BROKE OFF INTRAOPERATIVELY AND COULD NOT BE RETRIEVED. THE PIECE WAS LEFT IN THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENTS' CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 18826919 ↗
• MalfunctionFeb 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE TIP OF ONE (1) 7.0 COMPRESSION SCREW DRILL BROKE OFF. THE BROKEN PIECE WAS RETRIEVED. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 18732286 ↗
• InjuryFeb 14, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION PROCEDURE, THE TIP OF ONE (1) 7.0 COMPRESSION SCREW DRILL BROKE OFF WHILE IN USE. THE PIECE WAS RETRIEVED. ADDITIONALLY, THERE WAS A FRACTURE LINE ON THE BONE WHICH WAS FIXED USING A CABLE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH AN S+N BACK-UP DEVICE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 18707419 ↗
• MalfunctionJan 30, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING SURGERY, THE TIP OF THE SCREW DRILL WAS BROKEN WHILE IN USE. THE BROKEN TIP WAS RETRIEVED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607755 ↗
• MalfunctionJan 15, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TRAUMA SURGERY, THE TIP OF ONE (1) 7.0 COMPRESSION SCREW DRILL WAS BROKEN INSIDE THE PATIENT WHILE IN USE. THE BROKEN TIP WAS RETRIEVED AND THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING 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 18512488 ↗
• MalfunctionNov 14, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, JUST AFTER THE DRILLING WAS STARTED THE TIP OF A 7.0 COMPRESSION SCREW DRILL WAS BROKEN, THE PIECE WAS RETRIEVED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 18133867 ↗
• MalfunctionNov 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, WHEN DRILLING THE TIP OF ONE (1) 7.0 COMPRESSION SCREW DRILL WAS BROKEN. THE PIECE FELL INSIDE THE WOUND WAS RETRIEVED AND ACCOUNTED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 18122606 ↗

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