TRIGEN 71631021Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 03596010604873), received between Jun 21, 2020 and May 7, 2026 — classified as 5 injuries, 12 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Difficult or Delayed Positioning; Calibration Problem; Material Deformation

  IT WAS REPORTED THAT, DURING AN INTRAMEDULLARY NAIL SURGERY, WHEN THE NAIL WAS BEING INSERTED AND AN IMPACT WAS INTENDED, THE IMPACTOR DID NOT FIT INTO ONE (1) TAN/FAN PERC DRILL GUIDE (THE IMPACTOR IS VISIBLY IN GOOD CONDITION, WHICH IS WHY A FRAME FAILURE IS SUSPECTED). ADDITIONALLY, BEFORE ENTERING THE NAIL INTO THE PATIENT, THE PROXIMAL LOCKS WERE CHECKED, BUT WHEN IT WAS IN THE BONE, THEY WERE OUT OF CALIBRATION (AND THE NAIL WAS TIGHTENED QUITE TIGHTLY SO THAT IT WOULD NOT LOOSEN WITH THE HAMMER BLOWS).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 25112868 ↗
• MalfunctionDec 18, 2025Failure to Align; Material Deformation; Failure to Align; Material Deformation

  IT WAS REPORTED THAT DURING A TRAUMA 02 INTRA-FEMORAL ROD (TAN) PROCEDURE, AND WHILE FOLLOWING THE INSTRUCTIONS FOR USE, IT WAS IDENTIFIED THAT THE HOLE ALIGNMENT ON ONE (1) 13 X 36 130 D TAN LT LIME ROD WAS INCORRECT. USING THE PERCUTANEOUS DRILL GUIDE, TWO ATTEMPTS WERE MADE TO ADJUST THE GUIDE ANTERIORLY, BUT ALIGNMENT COULD NOT BE ACHIEVED. THE SURGEON SUBSEQUENTLY ELECTED TO USE A COMPETITOR'S DEVICE, DESPITE THE TAN ROD AND THREE GUIDE WIRES ALREADY BEING OPENED. ADDITIONALLY, DURING THE SAME PROCEDURE AND WHILE DRILLING PROXIMALLY FOR ROD FIXATION, A DEVIATION BETWEEN THE ROD AND ONE (1) TAN/FAN PERC DRILL GUIDE WAS OBSERVED. THE SURGEON ATTEMPTED CORRECTION TWICE WITHOUT SUCCESS. WHEN THE ROD WAS MOUNTED ON THE GUIDE OUTSIDE THE PATIENT, MISALIGNMENT WAS AGAIN CONFIRMED, AS THE DRILL BIT TRAJECTORY FELL OUTSIDE THE ROD HOLE. IT WAS ALSO NOTED THAT THE GUIDE CONTAINED IMPACT MARKS, POSSIBLY INDICATING PRIOR DAMAGE OR MISALIGNMENT. THE SURGEON PROCEEDED WITH COMPETITOR INSTRUMENTATION, EVEN THOUGH THE TAN ROD AND THREE GUIDE WIRES HAD ALREADY BEEN OPENED. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER AN APPROXIMATE 30-MINUTE DELAY. A POTENTIAL RISK OF INJURY, FEMORAL CANAL FIX

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23837757 ↗
• InjuryMay 4, 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 RADIOLUCENT 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 14282552 ↗
• 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 13113696 ↗
• MalfunctionAug 5, 2021Break; Defective Device; Break; Defective Device

  IT WAS REPORTED THAT A TAN/FAN PERC DRILL GUIDE WAS BROKEN AND DID NOT FIT IN OTHER PIECES. AS THIS WAS NOTICED DURING INSPECTION NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12285603 ↗
• MalfunctionJun 24, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, TRIEGEN TAN/FAN PERCUTANEOUS DRILL GUIDE BROKE OUTSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT DELAY, USING A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12063638 ↗
• 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 11783119 ↗
• 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 (CASE-(B)(4)) AND TAN/FAN RADILUCENT DROP (CASE-(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 11783057 ↗
• MalfunctionMar 19, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A ROUTINE CHECK, IT WAS DISCOVERED THAT THE IMPACTOR HAD SHEERED OFF IN THE DRILL GUILD. NO CASE OR PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11526035 ↗
• MalfunctionMar 14, 2021Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT, DURING SET UP FOR A IM NAIL PROCEDURE, THE BOLT FROM BROKEN IMPACTOR IS STUCK IN THE THREADS AND CANT BE REMOVED. PROCEDURE WAS PERFORMED WITH A BACKUP DEVICE, NO DELAY OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11478864 ↗
• 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 11458342 ↗
• MalfunctionMar 3, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING A SURGERY THE TAN/FAN PERC DRILL GUIDE WAS NOT SCREWING INTO THE NAIL CORRECTLY WHILE OUTSIDE THE PATIENT. THE SURGERY WAS COMPLETED WITH A BACK UP DEVICE AND WITH NO DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11407063 ↗
• MalfunctionFeb 2, 2021Connection Problem; Material Twisted/Bent; Connection Problem; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING SURGERY, PRONGS THAT HOLD NAIL OF THE PERCUTANEOUS DRILL GUIDE DEVICE ARE BENT AND WON'T RELEASE THE NAIL PROPERLY. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11270630 ↗
• MalfunctionDec 30, 2020Connection Problem; Material Twisted/Bent; Connection Problem; Material Twisted/Bent

  IT WAS REPORTED THAT DURING PROCEDURE, TAN/FAN PERC DRILL GUIDE 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 11095403 ↗
• 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 Known Impact Or Consequence To Patient

  MAUDE report 10737842 ↗
• 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 10177298 ↗
• 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 Known Impact Or Consequence To Patient

  MAUDE report 10177297 ↗

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