TRIGEN 71751140Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 03596010515483), received between Jul 16, 2020 and Nov 24, 2025 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A HUMERAL NAIL SURGERY, THE END OF TWO (2) HUMERAL 3.5MM HEXDRIVER, SNAPPED OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23638321 ↗
• MalfunctionMay 27, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, AT THE FINAL STEP OF IMPLANTING, THE TIP OF THE HUMERAL 3.5MM HEXDRIVER WAS BROKEN ON THE SIDE FURTHEST TO THE SCREW. WHEN, USED THE TECH THREADS IT TO THE SCREW USING THE BUILT IN CAPTURE, THAT BUILT IN CAPTURE DID NOT RELEASE THE SCREW. SURGEON GOT A NEEDLE HOLDER AND KEPT TURNING TO RELEASE THE SCREW WHICH IT DID. BUT ALSO MANAGED TO BREAK THE PROXIMAL PART OF THE SCREW CAPTURE DEVICE. NO PIECE FELL INSIDE THE PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, RELEASING THE DRIVER OF THE SCREW. PATIENT'S CURRENT STATUS IS SATISFACTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22092127 ↗
• MalfunctionDec 13, 2024Material Deformation; Mechanics Altered; Material Deformation; Mechanics Altered

  IT WAS REPORTED THAT DURING SURGERY, TWO (2) HUMERAL 3.5MM HEXDRIVER WERE NOT GRABBING ONTO LOCKING SCREW. THE PROCEDURE WAS ABLE TO BE COMPLETED BY CHANGE IN SURGICAL TECHNIQUE AFTER A SIGNIFICANT DELAY. SURGERY WAS NOT DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20924386 ↗
• MalfunctionNov 7, 2023Fracture; Mechanics Altered; Fracture; Mechanics Altered

  IT WAS REPORTED THAT DURING PROCEDURE, TWO (2) HUMERAL 3.5MM HEXDRIVER WERE ARE NOT CAPTURING THE SCREWS PROPERLY; FURTHERMORE, THE BACK OF ONE OF THE DRIVERS SNAPPED OFF WHILE ATTEMPTING TO CAPTURE THE SCREW. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18084816 ↗
• MalfunctionSep 21, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, THE TIP OF A HUMERAL 3.5MM HEXDRIVER CRACKED/SNAPPED. SURGERY WAS PERFORMED, WITHOUT 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 15461764 ↗
• MalfunctionMay 21, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, THE CAPTURE PART ON A TRIGEN HUMERAL 3.5MM HEXDRIVER BROKE OUTSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14467037 ↗
• MalfunctionMar 23, 2022Break; Break

  IT WAS REPORTED THAT THE CAPTURE OF A HUMERAL 3.5MM HEXDRIVER BROKE. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13866536 ↗
• MalfunctionNov 15, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE RETAINING ROD INSIDE A HUMERAL 3.5MM HEXDRIVER BROKE. 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 12816988 ↗
• MalfunctionJun 14, 2021Connection Problem; Naturally Worn; Connection Problem; Naturally Worn

  IT WAS REPORTED THAT A HUMERAL 3.5MM HEXDRIVER HAD AN UNSPECIFIED FAILURE. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED. AFTER INVESTIGATION IT WAS NOTICED THAT THE DEVICE WAS PAIRED WITH THE MATING PART MECHANISM AND DOES NOT FUNCTION AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11995898 ↗
• MalfunctionMay 11, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT, THE SCREWS ON TWO (2) HUMERAL 3.5MM HEXDRIVER FOR THE HUMERAL NAIL FELT LOOSE WHEN TIGHTENING. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11806029 ↗
• MalfunctionMay 11, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT, THE SCREWS ON TWO (2) HUMERAL 3.5MM HEXDRIVER FOR THE HUMERAL NAIL FELT LOOSE WHEN TIGHTENING. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11805887 ↗
• MalfunctionApr 5, 2021Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE BACK END OF THE INNER SLEEVE OF THE HUMERAL 3.5MM HEXDRIVER BROKE OFF WHILE THE DEVICE WAS OUTSIDE THE PATIENT. THE PROCEDURE WAS FINISHED USING A BACKUP DEVICE FROM SMITH AND NEPHEW, WITHOUT SURGICAL DELAY AND NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11612181 ↗
• MalfunctionDec 9, 2020Break; Break

  IT WAS REPORTED THAT, DURING THE PROCEDURE, THAT THE RETAINING RODS BROKE OFF FROM THE SCREWDRIVER. THE INCIDENT OCCURRED OUTSIDE THE PATIENT. IT IS UNKNOWN IF THERE WAS A DELAY AND HOW WAS THE SURGERY FINISHED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10978308 ↗
• MalfunctionNov 16, 2020Break; Break

  IT WAS REPORTED THAT THE THUMBSCREW ON HEXDRIVER IS BROKEN OFF. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10849595 ↗
• MalfunctionOct 19, 2020Break; Break

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE HUMERAL 3.5MM HEXDRIVER WAS FOUND BROKEN. THE INSTRUMENT WAS OUTSIDE OF PATIENT. PROCEDURE FINISHED WITH S&N BACKUP DEVICE. SURGERY WAS NOT DELAYED. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10700425 ↗
• MalfunctionOct 19, 2020Break; Break

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE HUMERAL 3.5MM HEXDRIVER WAS FOUND BROKEN. THE INSTRUMENT WAS OUTSIDE OF PATIENT. PROCEDURE FINISHED WITH S&N BACKUP DEVICE. SURGERY WAS NOT DELAYED. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10700398 ↗
• MalfunctionOct 5, 2020Break; Break

  IT WAS REPORTED THAT THE DRIVER WAS TORQUED TOO MUCH AND CAPTURE WAS TIGHTENED TOO MUCH CAUSING THE INSTRUMENT TO BREAK. IT IS UNKNOWN WHETHER THE INCIDENT HAPPENED OR NOT IN A SURGICAL ENVIRONMENT OR AS CONSEQUENCE OF A SURGERY. 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 10632387 ↗
• MalfunctionOct 5, 2020Defective Device; Defective Device

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10632342 ↗
• MalfunctionSep 11, 2020Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE HUMERAL 3.5MM HEXDRIVER BROKE OUTSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, WITHOUT DELAY, USING A BACK-UP DEVICE. THE PATIENT WAS NOT HARMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10524443 ↗
• MalfunctionJul 16, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE HUMERAL HEXDRIVER THE RETAINING RODS DO NOT TURNS INSIDE OF IT. THE HUMERAL RULER WAS FOUND WITH BLACK PIECE AT THE END CRACKED AND THE HUMERAL NAIL OBTURATOR IS BENT. THIS HAPPENED OUTSIDE OF MEDICAL ENVIRONMENT. NO CASE INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10281392 ↗

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