TRIGEN 71631022Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 03596010604880), received between Jun 21, 2020 and Sep 28, 2022 — classified as 7 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (2 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT, DURING THE OSTEOSYNTHESIS SURGERY PERFORMED ON (B)(6) 2022, THE SURGEON COULD NOT PLACE THE 6.4 SOLID HIP SCREWS IN THE NAIL. AS REPORTED, WHEN PASSING THE DRILL BIT THROUGH THE TAN/FAN RADILUCENT DROP, IT WOULD NOT TARGET THE NAIL CORRECTLY. THE SURGEON QUESTIONED THE CORRECT CALIBRATION OF THE DEVICE. WHEN THE DEVICE WAS CHECKED OUTSIDE THE PATIENT, IT WAS WORKING., THEREFORE THE SURGEON SUSPECTED THAT THE DROP WAS DAMAGED WHILE INSERTING THE NAIL IN THE PATIENT. AS NO OTHER OPTION WAS AVAILABLE AT THE TIME, THE SURGEON COMPLETED THE PROCEDURE USING THE SAME DEVICES RESULTING IN A FEMORAL NECK MAL-REDUCTION. THE PATIENT UNDERWENT AN UNSPECIFIED INTERVENTION TO ADDRESS THE ISSUE ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15495975 ↗
• InjuryMay 5, 2022Failure to Calibrate; Failure to Calibrate

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE CALIBRATION OF A TAN/FAN PERC DRILL GUIDE AND A TAN/FAN RADILUCENT DROP WERE NOT ACCURATE, CAUSING ONE OF THE TWO SCREWS TO BE LEFT OUT OF THE NAIL. SURGERY WAS FINISHED, AFTER A DELAY GREATER THAN 30 MINUTES, WITH THE SAME DEVICE. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14288539 ↗
• MalfunctionDec 29, 2021Failure to Align; Failure to Align

  IT WAS REPORTED THAT, DURING A TRIGEN TAN SURGERY, THE DOCTOR FACED SEVERAL ISSUES WITH ITS INSTRUMENTS. ALSO, THERE WAS MISMATCH/ALIGNMENT BETWEEN HOLE AND DRILL BIT. SURGERY WAS RESUMED, WITH A GREATER THAN 30 MINUTES DELAY, WITH A COMPETITOR DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13110694 ↗
• MalfunctionAug 4, 2021Break; Break

  IT WAS REPORTED THAT A TAN/FAN RADIOLUCENT DROP WAS BROKEN AND DID NOT CONNECT. THIS EVENT WAS NOTICED DURING INSPECTION THEREFORE NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12276576 ↗
• InjuryMay 6, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING A TRAUMA SURGERY, AFTER USING THE TAN/ FAN PERC DRILL GUIDE ((B)(4)) AND TAN/FAN RADILUCENT DROP ((B)(4)) THE DRILL MISSED TO TARGET THE NAIL. THE PROCEDURE WAS COMPLETED WITH A DELAY GREATER THAN 30 MINUTES USING A COMPETITORS DEVICE. THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11783146 ↗
• InjuryMay 6, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING A TRAUMA SURGERY, AFTER USING THE TAN/FAN PERC DRILL GUIDE (B)(4) AND TAN/FAN RADIOLUCENT DROP (B)(4) THE DRILL MISSED TO TARGET THE NAIL. THE PROCEDURE WAS COMPLETED WITH A DELAY GREATER THAN 30 MINUTES USING A COMPETITORS DEVICE. THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11783086 ↗
• MalfunctionMar 11, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A PROCEDURE THE TAN/FAN PERC DRILL GUIDE AND THE TAN/FAN PERC RADILUCENT DROP WERE VERY DIFFICULT TO ASSEMBLE AND DISASSEMBLE. THERE WAS NO INJURIES REPORTED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND NO SIGNIFICANT DELAYS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11458347 ↗
• MalfunctionDec 30, 2020Connection Problem; Material Twisted/Bent; Connection Problem; Material Twisted/Bent

  IT WAS REPORTED THAT DURING PROCEDURE, TAN/FAN RADIOLUCENT DROP WAS BENT AND NOT ABLE TO CONNECT PROPERLY. NO HARM OR INJURY REPORTED ON PATIENT. PROCEDURE WAS FINISHED WITH THE SAME DEVICE. NO DELAY 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 11095362 ↗
• MalfunctionOct 26, 2020Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE DROP AND GUIDE ARE NOT ALIGNED CORRECTLY DURING FAN NAIL CASE. BOTH WERE IN THE SAME CASE. THE PROCEDURE WAS COMPLETED USING A S+N BACKUP DEVICE. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10737935 ↗
• InjuryAug 18, 2020Break; Break

  IT WAS REPORTED THAT THE DRILL GUIDE IS NOT FITTING INTO THE DROP DUE TO A BROKEN O RING. EVENT OCCURRED DURING USE WITH INSTRUMENTS INSIDE THE PATIENT. PROCEDURE WAS COMPLETED USING A SN BACKUP DEVICE. A DELAY OF LESS THAN 30 MINUTES WAS REPORTED. ANY OTHER ISSUE THAT COULD AFFECT THE PATIENT'S CONDITION WAS NOT REPORTED BY THIS EVENT. 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 Information

  MAUDE report 10423157 ↗
• InjuryJun 21, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING TRAUMA SURGERY - INTERTAN TAN HIP FRACTURE REPAIR. TARGETING IS OFF WITH GUIDE AND DROP, THEREFORE SCREWS AREN'T ALIGNING WITH NAIL. THERE WAS A DELAY WAS UNDER 30 MINUTE HOWEVER THE ADDED TIME KEEPS THE PATIENT UNDER ANESTHESIA LONGER THAN NECESSARY. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE AND THE SURGEON CHANGING THEIR TECHNIQUE- TO A FREEHAND APPROACH TO TARGET SCREWS. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10177292 ↗
• InjuryJun 21, 2020Malposition of Device; Activation, Positioning or Separation Problem; Malposition of Device; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING TRAUMA SURGERY - INTERTAN TAN HIP FRACTURE REPAIR. TARGETING IS OFF WITH GUIDE AND DROP, THEREFORE SCREWS AREN'T ALIGNING WITH NAIL. THERE WAS A DELAY WAS UNDER 30 MINUTE HOWEVER THE ADDED TIME KEEPS THE PATIENT UNDER ANESTHESIA LONGER THAN NECESSARY. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE AND THE SURGEON CHANGING THEIR TECHNIQUE- TO A FREEHAND APPROACH TO TARGET SCREWS. NO INJURY REPORTED.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10177291 ↗

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