TRIGEN 71631068Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 03596010478436), received between Jun 8, 2020 and May 5, 2026 — classified as 5 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Break” (23 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 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Fracture

  IT WAS REPORTED THAT, DURING A IM HIP NAIL SURGERY, THE THREADED COUPLING SCREW ON ONE (1) SHORT HEXDRIVER WAS FRACTURED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25083965 ↗
• MalfunctionApr 18, 2026Fracture

  IT WAS REPORTED THAT, DURING AN IM TIBIA ROD SURGERY, THE TIP OF ONE (1) SHORT HEXDRIVER BROKE WHILE TIGHTENING SCREW. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24919871 ↗
• MalfunctionFeb 12, 2026Fracture

  IT WAS REPORTED THAT, DURING A FEMUR INTRAMEDULLARY NAILING SURGERY, THE THREADED CAPTURE OF ONE (1) SHORT HEXDRIVER BROKE DURING SCREW INSERTION. THE PROCEDURE HAD BEEN COMPLETED, WITHOUT ANY DELAY, USING THE SAME DEVICE. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24327221 ↗
• MalfunctionAug 27, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A REMOVAL PROCEDURE, THE INTERNAL CAPTURE OF ONE (1) SHORT HEXDRIVER BROKE AT THE THREADS. NO PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A S+N BACKUP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22901434 ↗
• MalfunctionSep 16, 2024Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SHORT HEXDRIVER BROKE DURING SCREW INSERTION. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY OR HOW THE PROCEDURE WAS COMPLETED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20225262 ↗
• MalfunctionAug 28, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING HINDFOOT FUSION NAIL PROCEDURE, WHEN UNSCREWING THE CAPTURE ROD THE SHORT HEXDRIVER TIP BROKE OFF. NO PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20092287 ↗
• MalfunctionMar 26, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION PROCEDURE, A PIECE OF ONE (1) SHORT HEXDRIVER BROKE. THE BREAKAGE OCCURRED OUTSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18983900 ↗
• MalfunctionFeb 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, THE INSERT FOR THE SHORT HEXDRIVER WAS SNAPPED OFF AT THE END SO THE INSERT DIDN'T STICK PAST THE END OF THE DRIVER, NOT ALLOWING THE SCREW TO BE ATTACHED TO THE DRIVER. 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 18627753 ↗
• MalfunctionSep 21, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY OF A FEMUR AND TIBIA FRACTURE, AFTER SEVERAL ATTEMPTS TO TIGHTEN THE CAP, IT WAS STILL LOOSE. THE SURGEON TIGHTEN THE CAP INTO THE SHORT HEXDRIVER AND WHEN THE CAP WAS CORRECTLY POSITIONED IN THE NAIL, IT GOT STUCK IN THE TIP OF THE SHORT HEXDRIVER AND THE TIP BROKE. THE BREAKAGE DID NOT OCCUR INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITHOUT THE CAP. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17790064 ↗
• InjuryMar 2, 2023Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  IT WAS REPORTED THAT DURING THE REMOVAL OF A TRIGEN META TIBIA, THE SHORT HEXDRIVER DEVICE DID NOT CONNECT PROPERLY TO THE SCREW HEAD AND THE SCREW HEAD WAS DAMAGED. IN ADDITION, THE TIP OF A COMPETITOR´S SCREW EXTRACTOR WAS BROKEN OFF. THE CORTICAL BONE AROUND THE SCREW HEAD WAS CUT SIGNIFICANTLY WITH A DIAMOND BAR IN ORDER TO USE THE SCREW GRIPPER DEVICE, BUT THE SCREW COULD NOT BE EXTRACTED. FINALLY, THE SCREW HEAD WAS BROKEN WITH A DRILL FROM ANOTHER COMPANY AND THE SCREW WAS EXTRACTED WITH A SCREW EXTRACTOR (EU000476-34). THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT (3H) DELAY.

  Patient problems: Laceration(s)

  MAUDE report 16469463 ↗
• MalfunctionFeb 21, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A NAIL SURGERY, THE TIP OF A SHORT HEXDRIVER FRACTURED. NO PIECES FELL INTO THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH 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 16414017 ↗
• MalfunctionFeb 14, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, THE TIP OF INNER CANNULA FOR SMALL SHORT HEXDRIVER WAS FOUND TO HAVE A SMALL CHIP IN IT, INHIBITING IT FROM HOLDING THE GOLD SCREW PROPERLY. THE DEVICE WAS LOCATED OUTSIDE THE PATIENT AT THE MOMENT OF THE ISSUE. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS ANY DELAY. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16371543 ↗
• MalfunctionOct 26, 2022Break; Break

  IT WAS REPORTED THAT THE TIP OF A SHORT HEXDRIVER WAS BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15674843 ↗
• MalfunctionSep 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING SET UP FOR A TRAUMA SURGERY, IT WAS NOTICED THAT THE TIP OF A SHORT HEXDRIVER WAS BROKEN. THE SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15501802 ↗
• InjurySep 12, 2022Fracture; Fracture

  IT WAS REPORTED THAT, THE RETAINING ROD OF A SHORT HEXDRIVER WAS FOUND TO BE SNAPPED. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAY. AS THIS WAS NOTICED DURING SETUP, THE PATIENT WAS NOT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15407859 ↗
• MalfunctionJul 13, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING SET UP OR INSPECTION, A SHORT HEX DRIVER BROKE OFF AT THREADS. NO CASE WAS REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15009281 ↗
• MalfunctionJun 19, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE INTERNAL CAPTURE OF A SHORIGHT HEXDRIVER BROKE OFF IN SCREW. NO PIECES FELL INSIDE OF 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 14741405 ↗
• MalfunctionMay 20, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING TRAUMA SURGERY WHEN THE SCREW WAS GOING INTO HARD BONE, THE DISTAL POINT OF THE RETAINING ROD ON A TRIGEN SHORT HEXDRIVER SHEERED OFF IN THE SCREW. NO BROKEN PIECES FELL IN THE PATIENT. THE SCREW WAS EXTRACTED AND REPLACED WITH A SMITH & NEPHEW BACK-UP DEVICE. THE SURGERY WAS NOT DELAYED, AND THE PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14454756 ↗
• MalfunctionApr 25, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT, DURING SURGERY, A SHORT HEXDRIVER WAS STRIPPED DURING CASE. SURGERY WAS FINISHED, WITHOUT ANY DELAY, WITH A SN BACK-UP DEVICE. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14192544 ↗
• MalfunctionApr 25, 2022Material Twisted/Bent; Mechanical Jam; Material Twisted/Bent; Mechanical Jam

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE SHORT HEXDRIVER INTERNAL CAPTURE WAS BENT AND STUCK. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT HARMED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14192401 ↗
• MalfunctionApr 4, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TRAUMA SURGERY, THE TIP OF A TRIGEN SHORT HEXDRIVER BROKE OUTSIDE THE PATIENT. NO PIECES FELL INTO PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, USING A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14003596 ↗
• MalfunctionApr 1, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE SHORT HEXDRIVER TIP BROKE OFF. NO PIECES FELL INSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS ISSUE. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13976083 ↗
• MalfunctionMar 20, 2022Break; Break

  IT WAS REPORTED THAT THE LOW PROFILE BROACH HANDLE IS DAMAGED NEAR THE TIP AND CANNOT ATTACH TO FEMALE COUNTERPART, AND THE SUBTROC LAG SCREW DRIVER IS BROKEN NEAR THE TIP. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13831340 ↗
• MalfunctionFeb 18, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING NAIL SURGERY THE SHORT HEXDRIVER WAS STRIPPED. THE PROCEDURE WAS COMPLETED, WITHOUT 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 13559619 ↗
• MalfunctionJan 24, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT A SHORIGHT HEXDRIVER IS ROUNDED. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13337878 ↗

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