TRIGEN 71631070Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 03596010519269), received between Sep 20, 2017 and Apr 28, 2026 — classified as 9 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Material Twisted/Bent; Premature Separation

  IT WAS REPORTED THAT, DURING A TIBIAL NAIL SURGERY, WHILE THE PROXIMAL SCREW WAS BEING INSERTED, IN THE LAST 10-15MM OF INSERTION, ONE (1) LONG HEXDRIVER DISCONNECTED FROM THE SCREW, SO IT COULD NOT BE INSERTED ANY FURTHER. UPON INSPECTION, THE CAPTURE OF THE LONG HEXDRIVER WAS FOUND TO BE STRIPPED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25017633 ↗
• MalfunctionJan 7, 2025Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE CAPTURE OF A LONG HEXDRIVER FOR BREAKING SCREW 5.0. THE CAPTURE OF THE LONG HEXDRIVER IS BROKEN, THE THREAD SIDE WAS BROKEN. ALSO THE TRIGEN LOW PROFILE SCREW 5.0MM X 50MM BROKE WHEN IT WAS GOING TO BE SCREW INTO THE SCREWDRIVER. 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 21092131 ↗
• InjuryApr 22, 2024Fracture; Separation Failure; Fracture; Separation Failure

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE TIP OF ONE (1) LONG HEXDRIVER BROKE AND ATTACHED TO THE INTERNAL HEX CAPTURED SCREW. DESPITE ATTEMPTS TO REMOVE THE BROKEN TIP, IT WAS NOT POSSIBLE, AND IT REMAINED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. IT IS STILL UNCLEAR WHETHER THERE WAS A DELAY. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 19160080 ↗
• InjuryJan 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT, ON (B)(6) 2023 DURING AN INTERNAL FIXATION SURGERY, THE TIP OF A LONG HEXDRIVER WAS NOTICED TO BE MISSING. THE SAME INSTRUMENT WAS USED IN A PREVIOUS INTERNAL FIXATION PROCEDURE ON (B)(6) 2023, AND WHEN X-RAYS OF THE PATIENT WERE REVIEWED, IT WAS CONFIRMED THE MISSING PIECE WAS LEFT INSIDE THE PATIENT, IN THE DISTAL CAPTURED SCREW HEAD. IT IS UNKNOWN IF AN ADDITIONAL PROCEDURE HAS BEEN SCHEDULED TO RETRIEVE THE BROKEN TIP. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 18544427 ↗
• MalfunctionOct 9, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TIBIAL NAIL PROCEDURE, THE TIP OF THE INNER RETAINING ROD OF THE LONG HEXDRIVER BROKE OFF DURING CAPTURE OF THE PROXIMAL SCREW INSERTION THROUGH THE META NAIL DRILL GUIDE. THE BROKEN PART WAS REMOVED AND DISPOSED OF IN A SHARPS CONTAINER. NO HEX DRIVER PIECE WAS LEFT INSIDE THE PATIENT AND CONFIRMED BY FLUOROSCOPY. 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 17897565 ↗
• MalfunctionNov 12, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, WHEN ATTEMPTING TO INSERT THE TRIGEN LOW PROFILE SCREW 5.0MM X 30MM THROUGH THE TARGETER, THE SCREW COULD NOT BE INSERTED. THE SCREW AND THE LONG HEXDRIVER WERE REMOVED AFTER CONFIRMED USING IMAGING THAT THE TIP OF THE LONG HEXDRIVER'S INNER ROD BROKE OFF AND THE PIECE WAS REMAINED INSIDE THE SCREW HEAD. SURGERY WAS RESUMED, AFTER A 5 MINUTES DELAY, WITH A BACK-UP SCREW AND DRIVER. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15785893 ↗
• MalfunctionApr 13, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT, A LONG HEXDRIVER HAS ROUNDED HEX END. AS THIS WAS NOTICED IN A FIELD INSPECTION, NOT PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14101824 ↗
• InjuryApr 4, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, WHEN TIGHTENING THE SCREW, THE INTERNAL CATCHING DEVICE FOR THE LONG HEXDRIVER WAS BROKEN INSIDE. THE TIP OF THE INNER CATCHING DEVICE BROKE INSIDE THE SCREW HEAD; THEREFORE UNABLE TO REMOVE IT OUT SINCE THERE IS NO MORE SPACE IN THE SCREW HEAD. PIECE WAS RETAINED INSIDE THE SCREW AND LEFT IMPLANTED IN THE PATIENT AS A RESULT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT HARMED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13996093 ↗
• MalfunctionFeb 27, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING SET UP FOR AN INTERNAL FIXATION SURGERY, THE LONG HEXDRIVER CAPTURE WAS BENT. AS THIS WAS NOTICED BEFORE THE PROCEDURE, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13615307 ↗
• MalfunctionFeb 27, 2022Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress; Material Twisted/Bent

  IT WAS REPORTED THAT A LONG HEXDRIVER IS BENT AND WILL NOT CAPTURE THE SCREWS. SINCE IT WAS NOTICED DURING AN INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13615228 ↗
• MalfunctionFeb 14, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE HEX END OF A LONG HEX DRIVER IS ROUNDED. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13529608 ↗
• InjuryJan 3, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, WHILE INSERTING THE SCREW USING A LONG HEXDRIVER, THE TIP OF THE INNER ROD BROKE OFF. THE PIECE WAS REMAINED INSIDE THE HEAD OF A TRIGEN LOW PROFILE SCREW 5.0MM X 30MM (CONCOMITANT), AND THEN, WAS REMOVED ALONG WITH THE SCREW. PIECES OF THE BROKEN DEVICE FELL INSIDE THE PATIENT, ALL WERE SUCCESSFULLY RETRIEVED. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE AND BACK-UP SCREW. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13142335 ↗
• InjuryDec 29, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE INTERNAL CATCHING DEVICE FOR THE LONG HEXDRIVER BROKE INSIDE THE SCREW WHEN TIGHTENING THE SCREW. SURGERY WAS COMPLETED, 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 13113076 ↗
• MalfunctionOct 8, 2021Break; Break

  IT WAS REPORTED THAT, A LONG HEXDRIVER IS BROKE. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12598223 ↗
• MalfunctionSep 8, 2021Break; Break

  IT WAS REPORTED THAT LONG HEXDRIVER BROKE AFTER WASH. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12441242 ↗
• MalfunctionSep 2, 2021Break; Break

  IT WAS REPORTED THAT DURING SET UP FOR A SURGERY, THE TIP OF A LONG HEXDRIVER BROKE. PROCEDURE WAS COMPLETED WITHOUT ANY DELAY, USING A BACKUP DEVICE. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12418520 ↗
• MalfunctionJun 24, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT, DURING TRAUMA SURGERY, A TRIGEN LONG HEXDRIVER WAS NOTICED TO BE STRIPPED, OUTSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH 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 12058263 ↗
• MalfunctionMay 24, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING SURGERY, THE LONG HEXDRIVER WAS STRIPPING. THERE WERE NO DELAYS AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11872879 ↗
• MalfunctionMay 13, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT, THE CAPTURES OF THE LONG HEXDRIVER IS DAMAGED. IT IS UNKNOWN WHEN THE EVENT HAPPENED AND IF THERE WAS A PATIENT INVOLVED. UPON VISUAL INSPECTION OF THE RETURNED DEVICE, IT WAS FOUND THAT THE TIP IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11822886 ↗
• MalfunctionMay 13, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, THE CAPTURES OF THE TWO LONG HEXDRIVERS ARE DAMAGED. IT IS UNKNOWN WHEN THE EVENT HAPPENED AND IF THERE WAS A PATIENT INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11822700 ↗
• MalfunctionMay 13, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, THE CAPTURES OF THE TWO LONG HEXDRIVERS ARE DAMAGED. IT IS UNKNOWN WHEN THE EVENT HAPPENED AND IF THERE WAS A PATIENT INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11822666 ↗
• MalfunctionMay 11, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING A TRAUMA SURGERY, A LONG HEXDRIVER WAS STUCK TO THE SCREW AND UNABLE TO DETACH. THE INSTRUMENT WAS INSIDE OF THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11807809 ↗
• InjuryMay 4, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TRAUMA PROCEDURE, THE TIP OF A LONG HEXDRIVER BROKE OFF . THE PIECE WAS INSIDE THE SCREW HEAD. THE SCREW WITH THE PIECE WAS REMOVED. INSTRUMENTS INSIDE PATIENT. THE PROCEDURE WAS COMPLETED USING A S+N BACK-UP DEVICE. SURGERY WAS 10 MIN DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11773331 ↗
• MalfunctionJan 6, 2021Crack; Crack

  IT WAS REPORTED THAT, DURING SET UP OR INSPECTION, TIP OF THE LONG HEXDRIVER DEVICE CRACKED. INCIDENT OCCURRED BEFORE THE PROCEDURE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11125716 ↗
• MalfunctionSep 22, 2020Break; Break

  IT WAS REPORTED THAT DURING INSPECTION PROCESS, THE THREADS OF THE LONG HEXDRIVER WERE SEEN TO BE BROKEN. THERE WAS NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10566426 ↗

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