TRIGEN 71654524Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 03596010644596), received between May 8, 2019 and Mar 11, 2025 — classified as 3 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING TRAUMA SURGERY, THE GUIDE BOLT SLEEVE OF ONE (1) SEMIEXTENDED DRILL GUIDE BROKE DURING THE CASE WHILE PHYSICIAN WAS HAMMERING THE NAIL DOWN. IT IS UNKNOWN IF THERE WAS A S&N BACKUP DEVICE AVAILABLE OR DELAY. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21572782 ↗
• MalfunctionOct 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, WHEN THE NAIL WAS BEING IMPACTED THE SEMIEXTENDED DRILL GUIDE BROKE IN TWO PIECES. 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 18021389 ↗
• MalfunctionJun 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING TRAUMA SURGERY FOR A MID-SHAFT TIBIA FRACTURE, ONCE THE TIBIAL NAIL WAS LOADED ON ONE (1) SEMIEXTENDED DRILL GUIDE AND FULLY SEATED IN THE TIBIA, IT WAS NOTICED THAT THE TOP GUIDE WAS LOOSE. THE LOOSE PART EVENTUALLY CAME APART AND THE META-NAIL ANTERIOR DROP COULD NOT BE ATTACHED FOR ACCURATELY TARGETING THE PROXIMAL SCREWS IN THE TIBIAL NAIL. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MINUTES, WITH 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 17108828 ↗
• MalfunctionDec 27, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING USE, A SEMIEXTENDED DRILL GUIDE SNAPPED. SURGERY WAS RESUMED, WITH A SIGNIFICANT DELAY, WITH A SMITH AND NEPHEW BACK UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16050332 ↗
• MalfunctionNov 9, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE PRONGS OF A SEMIEXTENDED DRILL GUIDE WERE BROKEN. 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 12783075 ↗
• MalfunctionJun 22, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, A SEMIEXTENDED DRILL GUIDE WAS NOT ABLE TO ASSEMBLE INTO DROP DURING NAIL CASE. 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 12042865 ↗
• MalfunctionMay 31, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING SEMI EXTENDED TRAINING, THE SEMIEXTENDED DRILL GUIDE WOULD NOT ENGAGE THE ANTERIOR DROP. UPON INSPECTION IT WAS DISCOVERED THAT ONE OF THE PEGS WAS BENT, NOT ALLOWING IT TO FIT. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11909247 ↗
• MalfunctionMay 17, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING TRAUMA SURGERY THE SEMIEXTENDED DRILL GUIDE BARELY FITS INTO THE META NAIL ANTERIOR DROP. SURGEON WAS FORCED TO HAMMER THE DROP INTO THE GUIDE. THE DROP IS NOT THE ISSUE, BECAUSE THE STANDARD DRILL GUIDE FITS PERFECTLY FINE INTO THE ANTERIOR DROP. THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE. NO INJURY OR SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11832854 ↗
• MalfunctionMay 13, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A SEMIEXTENDED DRILL GUIDE IS BENT. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS 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 11821075 ↗
• MalfunctionApr 26, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING SURGERY THE SEMIEXTENDED DRILL GUIDE WOULD NOT SEPARATE FROM THE META NAIL ANTERIOR DROP. NO DELAY WAS REPORTED AND THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE. NO PATIENT INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11729594 ↗
• InjuryApr 23, 2021Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE META NAIL SEMI EXTENDED DRILL GUIDE BROKE. INSTRUMENT WAS INSIDE OF THE PATIENT. IT IS UNKNOWN HOW SURGERY WAS COMPLETED AND IF IT WAS DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11720742 ↗
• MalfunctionApr 18, 2021Connection Problem; Naturally Worn; Connection Problem; Naturally Worn

  IT WAS REPORTED THAT, A META ANTERIOR DROP ((B)(4)) AND A SEMIEXTENDED DRILL GUIDE (SEMIEXTENDED DRILL GUIDE) WILL NOT LOCK IN PLACE, BOTH ITEMS ARE WORN. A BACKUP DEVICE WAS AVAILABLE, THERE WAS NO DELAY OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683485 ↗
• MalfunctionMar 28, 2021Connection Problem; Material Deformation; Connection Problem; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TOP OF THE SEMIEXTENDED DRILL GUIDE WAS STRIPPED. THE IMPACTOR COULD NOT THREAD ON. NO SIGNIFICANT DELAYS WERE REPORTED AND THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THE PATIENT WAS NOR HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11580426 ↗
• MalfunctionFeb 25, 2021Connection Problem; Material Deformation; Connection Problem; Material Deformation

  IT WAS REPORTED THAT DURING PROCEDURE WAS DIFFICULT TO THE SURGEON TO CONNECT THE THREE PRONGS OF THE SEMIEXTENDED DRILL GUIDE TO THE HOLES IN META ANTERIOR DROP. HAD TO USE QUITE A BIT OF FORCE IN ORDER TO CONNECT IT. THERE WAS A DELAY OF LESS THAN 30 MIN. PROCEDURE CONCLUDED WITH THE SAME DEVICES. AFTER PROCEDURE, IT WAS NOTICED METAL TIPS OF THE DRILL BENT CAUSING THE DROP GETTING DAMAGED AS WELL. 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 11376907 ↗
• MalfunctionFeb 3, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, THE SEMIEXTENDED DRILL GUIDE'S PRONG IS BENT. 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 11276852 ↗
• InjuryFeb 3, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING TRAUMA TIBIAL NAIL SURGERY THE SEMIEXTENDED DRILL GUIDE WAS NOT LINING WITH THE IMPLANT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A COMPETITOR DEVICE. NO OTHER COMPLICATIONS WERE REPORTED. 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 11270862 ↗
• MalfunctionDec 10, 2020Break; Break

  IT WAS REPORTED THAT A SEMIEXTENDED DRILL GUIDE BROKE APART DURING BACK SLAPPING. THIS OCCURRED WHEN THE INSTRUMENT WAS OUTSIDE THE PATIENT. NO HARM OR INJURY REPORTED ON PATIENT. PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. A LESS THAN 30 MINUTE DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10983029 ↗
• MalfunctionDec 1, 2020Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING SET UP/ INSPECTION THE JIG ON THE SEMIEXTENDED DRILL GUIDE WAS FOUND NOT LONGER CONNECTING TO THE DRILL GUIDE. THIS WAS A META NAIL CASE, THERE WAS NO DELAY AND A S&N BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO INJURIES REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10929395 ↗
• MalfunctionNov 17, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE SEMIEXTENDED DRILL GUIDE WAS FOUND BENT. IT IS UNKNOWN WHERE THE EVENT OCCURS.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 10850469 ↗
• MalfunctionNov 11, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT PRIOR TO SURGERY, DURING SET UP INSPECTION PROCESS WAS FOUND THAT THE THREADS OF THE SEMI EXTENDED DRILL GUIDE ARE WORN, AND THE IMPACTOR WILL NOT THREAD IN. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE, WITH NO SURGICAL DELAY AND NO INJURY TO THE PATIENT. 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; No Patient Involvement

  MAUDE report 10823342 ↗
• MalfunctionNov 2, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING PROCEDURE, SURGEON BEATED ON JIG AND DEVICE WOULD NOT ACCEPT BAT WING ANY LONGER. PROCEDURE CONTINUED WITH A BACK-UP DEVICE FROM SMITH AND NEPHEW, WITHOUT A DELAY. NO INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10774606 ↗
• MalfunctionOct 14, 2020Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING SURGERY. NO DELAY REPORTED. NO PATIENT INJURIES REPORTED. A S&N BACKUP WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10681295 ↗
• MalfunctionOct 7, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING INSPECTION THE SEMI EXTENDED INSTRUMENT TRAY AND LID WERE FOUND TO BE CRACKED AND PEALED, THE DRILL GUIDE WAS FOUND TO NOT PROPERLY ENGAGE AND DISENGAGE FROM THE DROP, AND THE GUIDE PIN SLEEVE WAS FOUND TO NOT PROPERLY INSERT AND RETRACT FROM THE TUBE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10642980 ↗
• MalfunctionJul 10, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A CASE, THE DOCTOR HIT THE BOTTOM OF THE TIBIA NAIL JIG WITH A MALLET AND NOW IT DOES NOT FIT INTO THE CARBON FIBER DROP. PROCEDURE WAS FINISHED WITH THE SAME DEVICE. NO DELAY WAS REPORTED. 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 10258395 ↗
• InjuryJun 24, 2020Mechanical Problem; Defective Device; Mechanical Problem; Defective Device

  IT WAS REPORTED THAT DURING SURGERY THE SEMI-EXTENDED DRILL GUIDE WAS FOUND SLIGHTLY BENT AND NOT ATTACHING TO THE DROP PROPERLY. SURGEON COULD NOT ATTACH THE META-NAIL ANTERIOR DROP TO THE DRILL GUIDE WITHOUT USING THE MALLET TO GENTLY TAP IT ON. THE MALLET IS NOT USED FOR THIS PURPOSE. THERE WAS ONLY ONE SET THERE. NO PIECE OF THE EQUIPMENT WAS LEFT BEHIND IN THE OPERATING ROOM PATIENT'S WOUND. THIS HELD UP THE CASE FOR A FEW MINUTES. NO INJURIES REPORTED. 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 10192296 ↗

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