TRIGEN 71674002Recalls & reported problems

Summary

The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 03596010570970), received between Nov 14, 2017 and Nov 10, 2025 — classified as 4 injuries, 74 malfunctions.

The most frequently reported specific device problem is “Break” (24 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 78 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2025Fracture; Failure to Align; Fracture; Failure to Align

  IT WAS REPORTED THAT, DURING A TRAUMA SURGERY IN THE RIGHT HIP, THE LOCKING OF ONE (1) 125 RAD DRILL GDE DROP FOR THE DISTAL SCREW WAS MISSING AND NOT IN LINE WITH THE HOLE ON THE SHORT 200MM INTERTAN NAIL. IT WAS STATED THAT IS POSSIBLE THAT THE 125 RAD DRILL GDE DROP IS CHIPPED WHERE THE SLEEVES ARE INSERTED. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, BY TAKING THE 125 RAD DRILL GDE DROP OFF AND PERFORMING A PERFECT CIRCLE TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23510917 ↗
• MalfunctionJul 9, 2025Failure to Align; Failure to Align

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION, ONE (1) 125 RAD DRILL GDE DROP WAS MISTARGETING THE DISTAL SCREWS IN A SHORT NAIL THAT MATCHED THE DEGREES. 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 22465302 ↗
• MalfunctionJul 9, 2025Failure to Align; Failure to Align

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, ONE (1) 125 RAD DRILL GDE DROP WAS NOT TARGETING THE DISTAL INTERLOCK 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 22465196 ↗
• MalfunctionJun 23, 2025Failure to Align; Failure to Align

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE TARGETING HOLE OF ONE (1) 125 RAD DRILL GUIDE DROP HAD WORN OVER TIME AND DISTAL SCREW IS MISSING THE SCREW HOLE. SURGEON HAD TO MAKE MULTIPLE ATTEMPTS TO DRILL THROUGH THE NAIL. SINCE THERE WAS A FAIR BIT OF PLAY BETWEEN THE DRILL SLEEVE AND THE DROP, THE DRILL KEPT MISSING THE DISTAL HOLE AND EITHER HIT THE NAIL OR DEFLECTED ANTERIOR. HE EVENTUALLY WAS SUCCESSFUL. THE PROCEDURE WAS RESUMED, WITHOUT ANY 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 22307586 ↗
• InjurySep 30, 2024Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT, ON (B)(6) 2024, DURING INTERNAL FIXATION SURGERY, DR. (B)(6) WAS IMPLANTING A SHORT INTERTAN NAIL INTO ONE OF HIS PATIENTS THAT PRESENTED WITH AN INTERTROCHANTERIC FRACTURE. WHEN IT CAME TO DRILLING FOR THE DISTAL INTERLOCK SCREW, THROUGH ONE (1) 125 RAD DRILL GDE DROP, THE DRILL MISSED THE SCREW HOLE THROUGH THE NAIL. AT FIRST, IT WAS THOUGHT THAT IT HIT THE NAIL'S EDGE, AND THEN IT DRILLED THROUGH THE SCREW HOLE. HOWEVER, AFTER TAKING A LATERAL X-RAYS, IT COULD BE SEEN THAT THE SCREW WAS POSTERIOR OUTSIDE OF THE NAIL. THE SCREW WAS REMOVED, A SECOND INTERTAN SET WAS OPENED, AND IT WAS USED ANOTHER 125 RAD DRILL GDE DROP, BUT THE SAME EXACT EVENT HAPPENED. THIS TIME, IT ENDED UP FRACTURING THE PATIENT'S FEMUR, AT THE LEVEL OF THE DISTAL INTERLOCK SCREW. THE PLACEMENT OF THE DISTAL INTERLOCK SCREW WAS ABORTED, AND IT WAS PLACED A COMPETITORS SYNTHES PROXIMAL FEMUR PLATE ON THE PATIENT'S FEMUR. THE NEXT DAY, THEY WENT THROUGH THE SYSTEM AND CHECKED EVERYTHING. IT WAS DISCOVERED THAT BOTH125 RAD DRILL GDE DROPS WERE LOOSE ENOUGH TO ALLOW A DRILL TO POTENTIALLY MISS THE SHORT NAIL. BOTH DROPS USED ON SAME HANDLE. THE PROCEDURE WAS COMPLETED AFTER A SIGNIFICANT DE

  Patient problems: Bone Fracture(s)

  MAUDE report 20333936 ↗
• MalfunctionSep 30, 2024Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT, ON (B)(6) 2024, DURING INTERNAL FIXATION SURGERY, DR. (B)(6) WAS IMPLANTING A SHORT INTERTAN NAIL INTO ONE OF HIS PATIENTS THAT PRESENTED WITH AN INTERTROCHANTERIC FRACTURE. WHEN IT CAME TO DRILLING FOR THE DISTAL INTERLOCK SCREW, THROUGH ONE (1) 125 RAD DRILL GDE DROP, THE DRILL MISSED THE SCREW HOLE THROUGH THE NAIL. AT FIRST, IT WAS THOUGHT THAT IT HIT THE NAIL'S EDGE, AND THEN IT DRILLED THROUGH THE SCREW HOLE. HOWEVER, AFTER TAKING A LATERAL X-RAYS, IT COULD BE SEEN THAT THE SCREW WAS POSTERIOR OUTSIDE OF THE NAIL. THE SCREW WAS REMOVED, A SECOND INTERTAN SET WAS OPENED, AND IT WAS USED ANOTHER 125 RAD DRILL GDE DROP, BUT THE SAME EXACT EVENT HAPPENED. THIS TIME, IT ENDED UP FRACTURING THE PATIENT'S FEMUR, AT THE LEVEL OF THE DISTAL INTERLOCK SCREW. THE PLACEMENT OF THE DISTAL INTERLOCK SCREW WAS ABORTED, AND IT WAS PLACED A COMPETITORS SYNTHES PROXIMAL FEMUR PLATE ON THE PATIENT'S FEMUR. THE NEXT DAY, THEY WENT THROUGH THE SYSTEM AND CHECKED EVERYTHING. IT WAS DISCOVERED THAT BOTH 125 RAD DRILL GDE DROPS WERE LOOSE ENOUGH TO ALLOW A DRILL TO POTENTIALLY MISS THE SHORT NAIL. BOTH DROPS USED ON SAME HANDLE. THE PROCEDURE WAS COMPLETED AFTER A SIGNIFICANT D

  Patient problems: Bone Fracture(s)

  MAUDE report 20333912 ↗
• InjuryOct 18, 2022Failure to Align; Failure to Align

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE DRILL GUIDE HANDLE AND THE 125 RADIOLUCENT DRILL GUIDE DROP WERE NOT ABLE TO TARGET THE DISTAL SCREW, WHEN THE SURGEON WENT DRILL THE PILOT HOLE FOR THE GOLD SCREW IT WAS HITTING THE NAIL. THE SURGEON WAS ABLE TO FREE HAND DRILL ANOTHER HOLE WITHOUT THE JIG. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN THE SURGICAL TECHNIQUE.

  Patient problems: Perforation

  MAUDE report 15626722 ↗
• MalfunctionSep 13, 2022Degraded; Degraded

  IT WAS REPORTED THAT, DURING NAILING PROCEDURE, THREE (3) 125 RAD DRILL GDE DROP ARE EXTENSIVELY WORN & UNUSABLE. THESE DROPS HAVE SEEN EXTENSIVE USE OVER THE PAST SEVERAL YEARS. THEY CONSISTENTLY MISS THE DISTAL LOCKING SCREWS FOR SHORT NAILS. SURGERY WAS PERFORMED, AFTER A SIGNIFICANT DELAY, AND WITH ANOTHER SURGICAL TECHNIQUE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15414128 ↗
• MalfunctionJan 13, 2022Break; Break

  IT WAS REPORTED THAT TWO (2) TRIGEN125 RADIOLUCENT DRILL GUIDE DROPS ARE BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13252044 ↗
• MalfunctionJan 13, 2022Break; Break

  IT WAS REPORTED THAT TWO (2) TRIGEN125 RADIOLUCENT DRILL GUIDE DROPS ARE BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13252041 ↗
• MalfunctionDec 13, 2021Break; Break

  IT WAS REPORTED THAT THE SPRING ON THE 125 RAD DRILL GDE DROP IS BROKEN AND WILL NOT HOLD THE DRILL SLEEVE. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12983561 ↗
• MalfunctionNov 18, 2021Break; Break

  IT WAS REPORTED THAT, A 125 RAD DRILL GDE DROP IS BROKEN. 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 12838771 ↗
• MalfunctionNov 9, 2021Break; Break

  IT WAS REPORTED THAT THE BUTTON TO LOCK THE 125 RADIOLUCENT DRILL GUIDE DROP INTO GUIDE IS BROKEN OFF. 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 12782859 ↗
• MalfunctionAug 25, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT, DURING SURGERY, A BLACK PIECE OF THE 125 RAD DRILL GDE DROP FELL DOWN. IT WAS FOUND DURING CALIBRATION, THEREFORE, THE DEVICE WAS OUTSIDE THE PATIENT. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS LESS THAN OR EQUAL TO 30 MINS DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12368609 ↗
• MalfunctionAug 5, 2021Break; Break

  IT WAS REPORTED THAT, DURING AND INTERNAL FIXATION SURGERY, A TRIGEN 125 RADIOLUCENT DRILL GUIDE DROP (CASE-(B)(4)) AND A TRIGEN SCREWDRIVER RELEASE HANDLE (CASE-(B)(4)) BROKE OUTSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, USING SMITH AND NEPHEW BACK-UP DEVICES. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12285493 ↗
• MalfunctionJul 7, 2021Break; Break

  IT WAS REPORTED THAT IN ONE (1) 125 RAD DRILL GDE DROP, ONE OF THE THREE (3) SPIKES HAS GONE OFF. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12132287 ↗
• MalfunctionJun 22, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A DRILL GUIDE DROP 125° DOESN'T LOCK PROPERLY. THE DEVICE HAS NOT BEEN USED IN ANY CASE; THEREFORE, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12042856 ↗
• MalfunctionJun 18, 2021Connection Problem; Naturally Worn; Connection Problem; Naturally Worn

  IT WAS REPORTED THAT, DURING SURGERY, A 125 RAD DRILL GDE DROP AND A LAG SCREW DRILL SLEEVE WERE WORN, MAKING IT DIFFICULT TO ENGAGE. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12028583 ↗
• MalfunctionJun 15, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING SURGERY, A LAG SCREW DRILL SLEEVE CONTINUOUSLY DISENGAGE FROM DROP. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12000382 ↗
• MalfunctionJun 9, 2021Naturally Worn; Physical Resistance/Sticking; Naturally Worn; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, A 125 RAD DRILL GDE DROP (CASE: (B)(6)) AND A LAG SCREW DRILL SLEEVE (CASE: (B)(6)) WERE NOTICED TO BE WORN AND WERE DIFFICULT TO DISENGAGE BETWEEN EACH OTHER. NO SIGNIFICANT SURGICAL DELAY WAS REPORTED DUE TO THIS EVENT, AND THE PROCEDURE WAS CONCLUDED USING THE SAME DEVICES. NEITHER PATIENT INJURY NOR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11963581 ↗
• MalfunctionJun 9, 2021Naturally Worn; Physical Resistance/Sticking; Naturally Worn; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, IT WAS NOTICED THAT A 125 RAD DRILL GDE DROP ((B)(4)) AND A LAG SCREW DRILL SLEEVE ((B)(4)) WERE WORN, MAKING IT DIFFICULT TO DISENGAGE. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11963574 ↗
• MalfunctionJun 3, 2021Failure to Disconnect; Naturally Worn; Failure to Disconnect; Naturally Worn

  IT WAS REPORTED THAT, DURING SURGERY, A 125 RAD DRILL GDE DROP AND A LAG SCREW DRILL SLEEVE WERE WORN, MAKING IT DIFFICULT TO DISENGAGE. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11934982 ↗
• MalfunctionMay 13, 2021Break; Break

  IT WAS REPORTED THAT DURING TRAUMA PROCEDURE, THE 125 RAD DRILL GDE DROP ((B)(4)) AND THE RULER ((B)(4)) BROKE WHILE OUTSIDE THE PATIENT. NO SURGICAL DELAY WAS REPORTED AND THE PROCEDURE WAS FINISHED USING SMITH AND NEPHEW BACK-UP DEVICES. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11817411 ↗
• MalfunctionMay 13, 2021Break; Break

  IT WAS REPORTED THAT DURING NAIL SURGERY BOTH THE RULER AND THE 125 RAD DRILL GDE DROP BROKE OUTSIDE THE PATIENT. A S+N BACKUP DEVICE WAS AVAILABLE. NO INJURY OR DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11816874 ↗
• MalfunctionMay 13, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING TRAUMA PROCEDURE, THE 125 RAD DRILL GDE DROP DID NOT HOLD THE SLEEVE IN PLACE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO PATIENT INJURY OR 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 11816594 ↗

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