TRIGEN 71751131Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010515438), received between Sep 25, 2020 and Jan 26, 2023 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• InjuryJan 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, AND AFTER INSERTING THE PROXIMAL AND DISTAL SCREWS USING A NAIL PROX DROP, IT WAS FOUND THAT DISTAL SCREW WAS NOT INSERTED TO A DISTAL HOLE. THIS WAS CONFIRMED BY IMAGING. THEREFORE, THE DISTAL SCREW WAS REMOVED AND AN ADDITIONAL BONE HOLE WAS NEEDED TO REINSERT THE SCREW. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

  Patient problems: Laceration(s)

  MAUDE report 16246934 ↗
• InjuryAug 24, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE SURGEON FOUND A SMALL METAL PIECE IN THE SURGICAL FIELD, THEN IT WAS DISCOVERED THAT A NAIL PROX DROP CONNECTION PART WAS REMOVED. THE PIECE WAS RETRIEVED. SURGERY WAS FINISHED WITHOUT ANY DELAY WITH THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15287922 ↗
• MalfunctionDec 15, 2021Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, A NAIL PROX DROP BROKE DURING NAIL PROCEDURE NOT ALLOWING SURGEON TO DRILL AND PUT SCREWS IN. DEVICE OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13012608 ↗
• MalfunctionSep 15, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION, A NAIL PROX DROP GUIDE 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 12478860 ↗
• InjuryApr 5, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SURGERY A HO LOAN KIT WAS USED AND SEVERAL INCONVENIENT WERE NOTICED. THE SURESHOT HUMERAL DRILL GUIDE PROBE FAILED. THE PROXIMAL JIG WAS FAULTY CAUSING ALL OF THE PROXIMAL SCREWS TO MISS THE NAIL. ALL SCREWS ENDED UP BEING DONE BY HAND MAKING PERFECT CIRCLES WITH BOTH DISTAL SCREWS AND PROXIMAL SCREWS. IT WAS REPORTED A SIGNIFICANT THE CASE ENDED UP DELAYED FOR OVER 2 HOURS. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11616782 ↗
• MalfunctionMar 30, 2021Break; Break

  IT WAS REPORTED THAT DURING AN INSPECTION IN THE WAREHOUSE IT WAS NOTICED THE FAILURE OF DEFECTIVE DEVICES. IT WAS NOTICED THAT THE NAIL PROX DROP ((B)(4)) HAS A DEFECTIVE ATTACHMENT. FOUR GENESIS II TIBIAL ALIGNMENT SPIKED FIXATION ROD ((B)(4)), THE SCREWDRIVER RELEASE HANDLE ((B)(4)), THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 5-6 9MM RIGHT ((B)(4)) , THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 5-6 9MM LEFT ((B)(4)), 0 DEG 32 MM TRIAL 48 MM ((B)(4)), THE HONEYCOMB ((B)(4)), THE BOX CHISEL ((B)(4)), JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 11 MM RIGHT ((B)(4)), THE LAG SCREW 3.2 GUIDE PIN SLEEVE ((B)(4)), THE MEDIUM HEXDRIVER ((B)(4)), THE SUBTROC LAG SCREW DRIVER ((B)(4)), THE ACCORD DUAL ENDED HEX DRIVER ((B)(4)) TWO THIN OSTEO BLADE 8X3 ((B)(4)), THE THIN OSTEO BLADE 12X3 ((B)(4)) AND THE JOURNEY DCF AP FEM CUT BLK 4 ((B)(4)) WERE NOTICED CRACKED. THE NAIL PROX DROP ((B)(4)), THE META ANTERIOR DROP ((B)(4)), THE MI Z HANDLE ACET REAMER ((B)(4)) AND TWO THIN OSTEO BLADE 8X3 ((B)(4)) WERE NOTICED BROKEN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593365 ↗
• MalfunctionMar 30, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING AN INSPECTION IN THE WAREHOUSE IT WAS NOTICED THE FAILURE OF DEFECTIVE DEVICES. IT WAS NOTICED THAT THE NAIL PROX DROP (B)(4) HAS A DEFECTIVE ATTACHMENT. THREE GENESIS II TIBIAL ALIGNMENT SPIKED FIXATION ROD (B)(4), THE SCREWDRIVER RELEASE HANDLE (B)(4), THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 5-6 9MM RIGHT (B)(4), THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 5-6 9MM LEFT (B)(4), 0 DEG 32 MM TRIAL 48 MM (B)(4), THE HONEYCOMB (B)(4), THE BOX CHISEL (B)(4), JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 11 MM RIGHT (B)(4) WERE NOTICED CRACKED. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593353 ↗
• MalfunctionDec 9, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING INSPECTION, IT WAS NOTICED THAT THE NAIL PROX DROP IS COMING APART, GUIDE WAS NOT TARGETING THE NAIL. THE PROCEDURE WAS FINISHED USING THE SAME DEVICE. THERE WAS A DELAY LESS THAN OR EQUAL TO 30 MINUTES. NO HARM TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10979056 ↗
• MalfunctionSep 25, 2020Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING INSPECTION PROCESS, THE NAIL PROX DROP WAS FOUND TO NOT CONNECT AND DISCONNECT PROPERLY. THERE WAS NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10590441 ↗

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