TRIGEN 71674001Recalls & reported problems

Summary

The FDA's MAUDE database contains 128 adverse event reports that list this exact device (DI 03596010560469), received between Jun 22, 2017 and Jul 3, 2026 — classified as 11 injuries, 117 malfunctions.

The most frequently reported specific device problem is “Break” (31 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 128 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2026Failure to Align

  IT WAS REPORTED THAT, DURING AN INTERTAN NAIL SURGERY, THE DISTAL 5.0MM TRIGEN SCREW WAS MISSING THE NAIL. THE JIG WAS NOT PROPERLY ALIGNED WITH THE NAIL. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25703831 ↗
• MalfunctionMar 9, 2026Failure to Align

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE DRILL GUIDE HANDLE CAUSED THE DRILL TO MISS THE DISTAL SCREW HOLE OF THE NAIL. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24543818 ↗
• MalfunctionJan 7, 2026Degraded

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) INTERTAN 3.2MM GUIIDE PIN SLEEVE, ONE (1) LAG SCREW DRILL SLEEVE, ONE (1) 130 RAD DRILL GDE DROP, ONE (1) ANTI ROTATION BAR, ONE (1) 125 RAD DRILL GDE DROP AND ONE (1) DRILL GUIDE HANDLE HAVE WEAR AND TEAR. ALSO, THESE DEVICES WERE STARTING TO FALL APART AND DID NOT GO SMOOTH DURING CASE. ADDITIONAL ANESTHESIA WAS NECESSARY FOR THE PROCEDURE. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23990184 ↗
• MalfunctionDec 9, 2025Positioning Failure; Failure to Align; Positioning Failure; Failure to Align

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, WHEN PERFORMING THE PROXIMAL (CEPHALIC) NAIL LOCKING, IT IS EVIDENT THAT ONE (1) LAG SCREW DRILL SLEEVE DO NOT FIT CORRECTLY TO THE NAIL FRAME. WHEN PASSING THE DRILL GUIDE HANDLE AND INTERTAN 3.2MM GUIIDE PIN SLEEVE FOR THE DOUBLE SCREW OR KIT, THEY ARE OVERMOUNTED. SIMILARLY, WHEN STARTING TO TIGHTEN THE SCREWS TO FIX THE FRACTURE, THE SCREW HEADS BEGIN TO RETRACT AND DEVIATE FROM THE PRE-DRILLED PATH. THE PROCEDURE WAS COMPLETED, AFTER NO DELAY, USING THE SAME S+N PRODUCT. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23764337 ↗
• MalfunctionDec 8, 2025Failure to Align; Failure to Align

  IT WAS REPORTED THAT, DURING A CMN SURGERY, ONE (1) DRILL GUIDE HANDLE WAS NOT TARGETING THE NAIL, IT MISSED. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IT THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23748436 ↗
• MalfunctionSep 18, 2025Failure to Align; Failure to Align

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE DISTAL SCREW WOULD NOT TARGET OFF THE JIG. THE PROCEDURE WAS RESUMED, AFTER A NON SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084116 ↗
• MalfunctionJul 29, 2025Break; Failure to Align; Break; Failure to Align

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE DRILL GUIDE HANDLE BUTTON FOR DROP BROKE, MADE IT DIFFICULT TO GET THE DROP ON AND OFF AND MAY HAVE CAUSED INACCURATE DISTAL SCREW TARGETING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22644843 ↗
• MalfunctionJul 9, 2025Failure to Align; Material Twisted/Bent; Failure to Align; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION, ONE (1) DRILL GUIDE HANDLE WAS CROOKED, IT WAS NOT TARGETING THE DISTAL SCREWS EITHER 125 OR 130 IN A SHORT NAIL. IT IS UNKNOWN HOW PROCEDURE WAS COMPLETED OR IF THERE WAS SURGICAL DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22465228 ↗
• MalfunctionJul 9, 2025Failure to Align; Failure to Align

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, ONE (1) DRILL GUIDE HANDLE WAS NOT TARGETING THE NAIL ACCURATELY. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. ALSO, IT IS UNKNOWN HOW WAS THE PROCEDURE FINISHED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22465068 ↗
• MalfunctionMay 11, 2025Fracture; Mechanical Problem; Failure to Align; Fracture; Mechanical Problem; Failure to Align

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, DURING THE INSERTION OF DISTAL SCREW, THE SCREW MISSED THE NAIL. THE SCREW DID NOT GO INTO THE NAIL AND WAS REMOVED. AN ADDITIONAL SCREW WAS PLACED USING THE PERFECT CIRCLES TECHNIQUE. IT SEEMED LIKE THE REASON THE SCREW MISSED THE NAIL WAS DUE TO THE DRILL GUIDE HANDLE (1) AND THE 130 RAD DRILL GDE DROP (1). THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 21999926 ↗
• MalfunctionJul 1, 2024Degraded; Material Fragmentation; Degraded; Material Fragmentation

  IT WAS REPORTED THAT, DURING INTERTROCHANTERIC FRACTURE ORIF SURGERY, ONE (1) DRILL GUIDE HANDLE WAS NOTICED TO BE BROKEN AND DETERIORATING AS IT IS LOSING GUIDE MARKERS IN THE RADIO. THE PROCEDURE WAS COMPLETED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19644096 ↗
• MalfunctionJun 3, 2024Failure to Align; Failure to Align

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, ONE (1) DRILL GUIDE HANDLE BECAME UNBALANCED WHICH REQUIRED THE BLOCKING TO BE DONE FREEHAND. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19454418 ↗
• MalfunctionApr 16, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE THREAD OF A DRILL GUIDE HANDLE WAS NOTICED TO BE DAMAGED WHERE THE IMPACTOR SCREWS INTO. THE PROCEDURE WAS PERFORMED, AFTER A SIGNIFICANT DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19122652 ↗
• InjuryJan 15, 2024Degraded; Degraded

  IT WAS REPORTED THAT, DURING AN INTERTAN NAIL SURGERY, IT WAS NOTICED THAT ONE (1) DRILL GUIDE HANDLE AND ONE (1) 125 RAD DRILL GDE DROP FAILED TO TARGET THE LAG SCREW AND DISTAL SCREW PROPERLY. BOTH INSTRUMENTS APPEAR TO BE WORN OUT. DURING THE PROCEDURE, THE LAG SCREW DRILL WAS BINDING IN THE JIG AND THE 5.0 DISTAL SCREW MISSED THE NAIL COMPLETELY. THE DRILL WENT POSTERIOR OF THE NAIL, WHICH WAS DISCOVERED ONLY AFTER INSERTING THE SCREW AND SHOOTING A LATERAL. THE MENTIONED SCREW WAS LEFT IN AS A BLOCKING SCREW, AND PERFECT CIRCLE TECHNIQUE WAS USED TO INSERT ANOTHER SCREW THROUGH THE NAIL. AFTER THIS, BOTH THE LAG SCREW AND COMPRESSION SCREW WERE IMPLANTED WITH NO ISSUE, IN THE CORRECT TARGETED LOCATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18510551 ↗
• MalfunctionDec 19, 2023Fracture; Material Fragmentation; Fracture; Material Fragmentation

  IT WAS REPORTED THAT, DURING SURGERY, IT WAS NOTICED THAT ONE (1) DRILL GUIDE HANDLE CROSS THREADED INTO JIG CAUSING JIG TO BE DAMAGED AS WELL. THREADED CAPTURE BROKE OFF THE END WHEN UNSCREWING IT FROM IMPLANT. 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 18356641 ↗
• MalfunctionOct 30, 2023Break; Crack; Break; Crack

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION, ONE (1) DRILL GUIDE HANDLE WAS BROKEN. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, BY 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 18029231 ↗
• InjuryAug 18, 2023Failure to Align; Failure to Align

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION, A DISTAL SCREW MISSED THE NAIL, AND THEN THE SCREW HEAD GOT STRIPPED WHILE TRYING TO REMOVE IT, SO THE SCREW HAD TO BE LEFT IN PLACE. NO OTHER DISTAL SCREW WAS ABLE TO BE PLACED PROPERLY, A SECOND SCREW WAS ATTEMPTED TO BE PLACED, BUT THE HEAD WAS TOO BIG TO PASS BY THE STRIPPED SCREW. THEREFORE, THE NAIL WAS NOT ABLE TO BE LOCKED. THE DRILL GUIDE HANDLE, TWO (2) 9MM DRILL SLEEVES, ONE (1) 4.0MM DRILL SLEEVE, AND THE LAG SCREW DRILL SLEEVE ARE SUSPECTED TO HAVE CAUSED THE MISPOSITIONING. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICES. PATIENT'S CURRENT HEALTH STATUS IS UNKNOW AND UNAVAILABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17574130 ↗
• MalfunctionMar 19, 2023Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING SURGERY FOR A INTERTROCHANTERIC HIP FRACTURE, INTRAMEDULLARY NAILING, WHEN DRILLING FOR THE DISTAL SCREW THROUGH THE 4.0/9.0 DRILL SLEEVE AND 125D DROP, THE 4.0MM DRILL BIT COULD NOT HIT ITS TARGET HOLE. RATHER THAN TARGET THE HOLE, THE ABOVE INSTRUMENTATION CAUSED THE DRILL BIT TO TARGET INTO THE METAL OF THE NAIL. THE GUIDE BOLT HOLDING THE INTERTAN SHORT NAIL SEEMED TO BE SECURE. IT HAD TO REMOVE THE DRILL GUIDE AND FINISH THE SURGERY BY FREEHAND LOCKING THE DISTAL SCREW. IT IS VERY LIKELY THAT SOME SORT OF DEFECT/WEAR ON THE INSTRUMENTS IS CAUSING MISALIGNMENT. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A CHANGE IN THE SURGICAL TECHNIQUE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16570458 ↗
• MalfunctionSep 20, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE CODING ON THE INSIDE OF THE DRILL GUIDE HANDLE IS BROKEN AND CRACKED. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15459962 ↗
• MalfunctionSep 13, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, THE INSIDE STRIP OF THE DRILL GUIDE HANDLE IS CRACK. AS THIS WAS NOTICE IN A FIELD INSPECTION, NOT PATIENT WAS INVOLVED. INVESTIGATION CONFIRMED THAT THE EPOXY COATING OVER THE INTERNAL WITNESS WIRE HAS DEGRADED AND HAS BEGUN TO COME OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15415427 ↗
• InjuryAug 31, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A FEMUR IMN PROCEDURE, THE DRILL GUIDE HANDLE BROKE WHERE THE BLACK CARBON FIBER GUIDE MEETS THE SILVER TIP THAT ATTACHES TO THE NAIL. ALL BROKEN FRAGMENTS WERE REMOVED WITH PITUITARY RONGEURS. SURGERY WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED BEYOND THE PROBLEM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15331212 ↗
• MalfunctionJul 13, 2022Fracture; Fracture

  IT WAS REPORTED THAT A DRILL GUIDE HANDLE IS DAMAGED. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED. INVESTIGATION DETERMINED THAT THE METAL PIECE IN THE MIDDLE TOP PART OF THE DEVICE IS CHIPPED, RENDERING IT INOPERATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14997253 ↗
• MalfunctionMay 11, 2022Crack; Crack

  IT WAS REPORTED THAT, THE INSIDE STRIP OF THE DRILL GUIDE HANDLE WAS SEEN TO BE CRACKED. AS THIS WAS NOTICE IN A FIELD INSPECTION, NOT PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14352649 ↗
• MalfunctionApr 19, 2022Break; Deformation Due to Compressive Stress; Break; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT A DRILL GUIDE HANDLE IS BROKEN AT THE THREADS AND WILL NOT ACCEPT THE IMPACTOR ANYMORE. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14141060 ↗
• MalfunctionApr 11, 2022Material Disintegration; Material Disintegration

  IT WAS REPORTED THAT, THE DRILL GUIDE HANDLE PLASTIC ON THE INTERIOR PART WAS ERODING. AS THIS HAPPENED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14072154 ↗

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