TRIGEN 71631024Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010604903), received between Jun 19, 2020 and Mar 12, 2025 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE OSTEOSYNTHESIS PROCEDURE, THE PERCUTANEOUS GUIDE BOLT FRACTURED, LEAVING ITS TIP INSIDE THE NAIL THAT WAS IMPLANTED IN THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: Foreign Body In Patient

  MAUDE report 21586971 ↗
• MalfunctionFeb 4, 2023Degraded; Fracture; Degraded; Fracture

  IT WAS REPORTED THAT, DURING A TRAUMA CASE, THE THREADS OF THE PERCUTANEOUS GUIDE BOLT SHEARED OFF WHILE TIGHTENING BOLT ONTO JIG. 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 16301805 ↗
• MalfunctionOct 4, 2022Separation Failure; Separation Failure

  IT WAS REPORTED THAT TRIGEN SURGERY, AFTER USING A FEMUR INTRAMODULAR NAIL AND APPLICATION OF LOCKING SCREWS, THE PERCUTANEOUS GUIDE BOLT DID NOT LEAVE THE NAIL, THE ALLOY SECTION IS DEFAULT AND THE 13 X 42 130 D TAN RT ROSE GOT DEFORMED. ANOTHER NAIL AND SET FROM S+N WAS APPLIED TO FINISHED THE SURGERY. A DELAY GREATER THAN 30 MIN WAS REPORTED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15535450 ↗
• MalfunctionJul 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A TRAUMA SURGERY, THE PERCUTANEOUS GUIDE BOLT BROKE ON INSERTION OF NAIL (THE BOLT BROKE AT THE JUNCTION OF THE NAIL GUIDE AND THE NAIL WHILE BEING INSERTED). NO PIECES FELL INTO THE PATIENT. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136632 ↗
• InjuryNov 26, 2021Break; Break

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE TIP OF A PERCUTANEOUS GUIDE BOLT BROKE INSIDE THE PATIENT. IT IS UNKNOWN IF THE PIECES WERE SUCCESSFULLY EXTRACTED. THERE WAS A SIGNIFICANT DELAY OF 30 MINUTES OR MORE AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED BEYOND THE DESCRIBED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12878046 ↗
• MalfunctionNov 15, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, A PERCUTANEOUS GUIDE BOLT ((B)(4).) BROKE INTO THE FEMORAL ANTEGRADE NAIL ROSE 10MM X 42CM RIGHT. SURGERY WAS RESUMED, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM. IT IS UNKNOWN IF THIS EVENT CAUSED ANY DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12816804 ↗
• MalfunctionMay 26, 2021Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, A META-TAN DRILL GUIDE, A PERCUTANEOUS GUIDE BOLT, AND A CANNULATED IMPACTOR - LONG BROKE. DEVICE OUTSIDE THE PATIENT. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. IT IS UNKNOWN IF SURGERY WAS DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11885810 ↗
• MalfunctionMar 3, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING A SURGERY THE PERCUTANEOUS GUIDE BOLT WAS NOT SCREWING INTO THE NAIL CORRECTLY WHILE OUTSIDE THE PATIENT. THE SURGERY WAS COMPLETED WITH A BACK UP DEVICE AND WITH NO DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11407298 ↗
• InjuryJun 19, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY WHEN WAS INSERT THE NAIL, THE GUIDE CAME OFF THE NAIL WHEN IMPACTING, THIS WAS BECAUSE THE TIP OF THE GUIDE BOLD BROKE OFF IN THE NAIL INSIDE THE PATIENT. THE GUIDE WAS REMOVED AND THE PIECE IN THE NAIL HAD TO BE FISHED OUT. THE SECOND GUIDE BOLT WAS USED AND THE NAIL WAS INSERTED. THE PROCEDURE HAD A DELAY BETWEEN 0-30 MIN. BACKUP FROM SMITH&NEPHEW WAS AVAILABLE.

  Patient problems: Injury

  MAUDE report 10174774 ↗

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