TRIGEN 71674003Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 03596010560476), received between Jul 22, 2019 and May 14, 2026 — classified as 4 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 51 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Premature Separation

  IT WAS REPORTED THAT, DURING A TRAUMA SURGERY, ONE (1) 130 RAD DRILL GDE DROP EXPERIENCED DISENGAGEMENT OF THE LAG SCREW WHEN FORCE WAS APPLIED, CAUSING THE SLEEVE TO SLIP OUT. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25172634 ↗
• MalfunctionDec 26, 2025Failure to Align; Material Deformation; Failure to Align; Material Deformation

  IT WAS REPORTED THAT, DURING A TRAUMA SURGERY, ONCE THE IMPLANT WAS PLACED INSIDE THE BONE, THE ORIENTATION FOR POSITIONING THE 130 RAD DRILL GDE DROP AND THE DRILL GUIDE HANDLE AND SECURING THE SCREWS DID NOT ALIGN WITH THE EXPECTED DIRECTION. AS A RESULT, THE INSTRUMENTATION APPEARED TO BE OUT OF PROPER CONDITION. THE PROCEDURE WAS PERFORMED, AFTER A 20 MIN, WITH A CHANGE IN SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23898452 ↗
• MalfunctionOct 22, 2025Failure to Align; Material Twisted/Bent; Failure to Align; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING AN IM NAIL PROCEDURE, ONE (1) 130 RAD DRILL GDE DROP WAS BENT, NOT TARGETING THE NAIL. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE USING THE PERFECT CIRCLE TECHNIQUE. NO ADDITIONAL ANESTHESIA WAS REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23360376 ↗
• MalfunctionJul 9, 2025Failure to Align; Failure to Align

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION, ONE (1) 130 RAD DRILL GDE DROP WAS MISTARGETING THE DISTAL SCREWS 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 22465224 ↗
• InjuryMay 22, 2025Failure to Align; Material Twisted/Bent; Physical Resistance/Sticking; Failure to Align; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION, ONE (1) 130 RAD DRILL GDE DROP WAS FOUND DIFFICULT TO PASS DUE TO CONSIDERABLE RESISTANCE. THE SPECIALIST WAS INSTRUCTED TO EXAMINE THE LOCKING HOLE UNDER IMAGE INTENSIFIER CONTROL AND VERIFY THE WAY IN WHICH THE RESIDENT WAS MANIPULATING THE INSTRUMENTS SINCE IT WAS EVIDENT THAT THE DRILL WAS PUTTING RESISTANCE AND WAS SLIGHTLY BENT. WHEN REMOVING THE DRILL, IT CAME OUT WITH TISSUE, SO THE 4.0 DRILL BIT AND THE LOCKING SLEEVES WERE CHANGED; HOWEVER, WHEN THE FRAME WAS RELEASED, THEY LOST THE INITIAL ORIENTATION OF THE NAIL. THE SPECIALIST DECIDED TO DO THE DRILL BIT AND IT WAS EVIDENT THAT THE DRILL BIT HIT THE NAIL. THE DRILL ADVANCED BEYOND THE CORTICES, IT WAS ABUNDANT BLEEDING THROUGH THE SLEEVE, AN IMAGE WAS TAKEN AGAIN AND IT WAS IDENTIFIED THAT THE DEEP FEMORAL ARTERY WAS INJURED WITH THE TIP OF THE DRILL, THE SLEEVES AND THE DISTAL LOCKING HANDLE WERE REMOVED. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. THE NAIL WAS LEFT UNFIXED IN THE DISTAL PART. THE PATIENT WAS STABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 22069225 ↗
• MalfunctionFeb 25, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, AFTER THE NAIL HAD BEEN SET, AN ATTEMPT WAS MADE TO SLIDE THE LAG SLEEVE INTO ONE (1) 130 RAD DRILL GDE DROP BUT THE SLIDE KEPT GETTING JAMMED AS THE BIGGER PORTION OF THE CYLINDER ENTERED THE SLEEVE. THE DOCTOR TRIED TO SLIDE THE SLEEVE IN WITH THE NAIL OUTSIDE THE PATIENT AND STILL HAD TROUBLES. THE PROCEDURE WAS RESUMED AFTER A SIGNIFICANT DELAY, WITH THE SURGICAL TECHNIQUE CHANGED TO REVERTING TO A 125-DEGREE NAIL USING THE 125 DROP. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21458614 ↗
• InjuryJul 8, 2024Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING AN INTERTAN PROCEDURE, WHEN PLACING THE DISTAL LOCKING SCREW OF THE NAIL, THE 130 RAD DRILL GDE DROP PRESENTED IMPRECISION WHEN PLACING THE DISTAL LOCKING THROUGH IT, LEAVING THE LOCKING SCREW BEHIND THE NAIL ON TWO OCCASIONS, FORCING TO DO UNCONVENTIONAL MANEUVERS TO MATCH THE INSTRUMENTS WITH THE NAIL HOLE. SURGERY WAS PERFORMED AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. PATIENT'S CURRENT HEALTH'S STATUS IS STABLE.

  Patient problems: Perforation

  MAUDE report 19689453 ↗
• MalfunctionApr 4, 2022Break; Break

  IT WAS REPORTED THAT, DURING INSPECTION BEFORE NAIL PROCEDURE, A 130 RAD DRILL GDE DROP WAS NOTICED TO BE BROKEN. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14002947 ↗
• MalfunctionMar 4, 2022Break; Break

  IT WAS REPORTED THAT DURING NAIL PROCEDURE, THE BUTTON THAT RELEASES 130 RAD DRILL GDE DROP SLEEVE BROKE OUTSIDE OF THE PATIENT. PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13667904 ↗
• MalfunctionFeb 17, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING INTERTAN SHORT NAIL SURGERY WHILE ASSEMBLING THE 130 RAD DRILL GD DROP, LAG AND COMPRESSION SLEEVE HOLDER DETACHED. AFTER INSERTING GOLD SCREW, THE CAPTURE OF THE SCREW THEN BROKE WHILE TRYING TO REMOVE IT (INSTRUMENTS OUTSIDE PATIENT). THE PROCEDURE WAS COMPLETED, WITH A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED BEYOND THE PROBLEM REPORTED. NO PIECES FELL INSIDE THE PATIENT, NO ADDITIONAL TREATMENT OR SURGICAL/MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13549054 ↗
• MalfunctionJan 7, 2022Break; Break

  IT WAS REPORTED THAT, DURING TRAUMA SURGERY, A TRIGEN 130 RADIOLUCENT DRILL GUIDE DROP AND A TRIGEN GRIPPER BROKE OUTSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICES. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13195217 ↗
• MalfunctionJan 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE GOLD LAG SCREW DRILL SLEEVE OF A 130 RAD DRILL GDE DROP UNCLIPS FROM THE DRILL GUIDE DROP WHEN RESISTANCE IS PRESENT. 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 13142265 ↗
• MalfunctionJul 7, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN UNKNOWN SURGERY, ONE (1) 130 RAD DRILL GDE DROP BROKE DURING NAIL PROCEDURE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. NO HEALTH CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12132353 ↗
• MalfunctionJun 9, 2021Naturally Worn; Physical Resistance/Sticking; Naturally Worn; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, A 130 RAD DRILL GDE DROP WAS NOTICED TO BE WORN AND WAS NOT EASILY DISENGAGED FROM A SLEEVE. NO SIGNIFICANT SURGICAL DELAY WAS REPORTED AS THE PROCEDURE WAS CONCLUDED USING THE SAME DEVICE. NEITHER PATIENT INJURY NOR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11963591 ↗
• MalfunctionJun 8, 2021Naturally Worn; Physical Resistance/Sticking; Naturally Worn; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, A 130 RAD DRILL GDE DROP WAS NOTICED TO BE WORN AND WAS NOT EASILY DISENGAGED FROM A SLEEVE. NO SIGNIFICANT SURGICAL DELAY WAS REPORTED AS THE PROCEDURE WAS CONCLUDED USING THE SAME DEVICE. NO PATIENT INJURY WAS REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11963553 ↗
• MalfunctionJun 3, 2021Failure to Disconnect; Naturally Worn; Failure to Disconnect; Naturally Worn

  IT WAS REPORTED THAT, DURING SURGERY, A 130 RAD DRILL GDE DROP WAS 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 11935453 ↗
• MalfunctionJun 3, 2021Failure to Disconnect; Naturally Worn; Failure to Disconnect; Naturally Worn

  IT WAS REPORTED THAT, DURING SURGERY, A 130 RAD DRILL GDE DROP WAS 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 11935408 ↗
• MalfunctionMay 24, 2021Break; Break

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE BUTTON OF A 130 RAD DRILL GDE DROP BROKE OUTSIDE THE PATIENT. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11871774 ↗
• MalfunctionMay 21, 2021Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT, DURING A TRAUMA PROCEDURE, IT WAS NOTICED THAT THE FOLLOWING INSTRUMENTS OF THE TRIGEN¿ INTERTAN¿ INSTRUMENT SET ARE WARPED DUE TO WEAR AND TEAR OVER PAST 3 YEARS: LAG SCREW DRILL SLEEVE ((B)(4)), INTERTAN 3.2MM GUIDE PIN SLEEVE ((B)(4)), LAG SCREW TAP ((B)(4)), LAG SCREW DRIVER ((B)(4)), COMPRESSION SCREW HEXDRIVER ((B)(4)), SUBTROC LAG SCREW DRIVER ((B)(4)), 130 RAD DRILL GDE DROP ((B)(4)), UNKNOWN TRIGEN INSTRUMENT ((B)(4)), UNKNOWN TRIGEN INSTRUMENT ((B)(4)). THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS GREATER THAN 30MINS DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11861872 ↗
• MalfunctionMay 20, 2021Connection Problem; Naturally Worn

  IT WAS REPORTED THAT AFTER AN UNSPECIFIED PROCEDURE, THE DRILL GUIDE HANDLE WAS WORN AND WAS DIFFICULT TO CONNECT TO THE 130 RAD DRILL GDE DROP. PROCEDURE FINISHED WITH SAME DEVICE. NO SURGICAL DELAY OR INJURY TO PATIENT REPORTED DUE THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11853770 ↗
• InjuryMay 13, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING TRAUMA SURGERY, THE 130 RAD DRILL GDE DROP DID NOT ALLOW THE SLEEVE TO GO THROUGH. THE PROCEDURE WAS FINISHED WITH AND SMITH AND NEPHEW BACK UP DEVICE (CHANGING THE NAIL SIZE FROM 130 DEGREE TO 125 DEGREE). NO INJURY TO THE PATIENT OR SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11816037 ↗
• MalfunctionMay 5, 2021Break; Break

  IT WAS REPORTED THAT, DURING INSPECTION, A 130 RAD DRILL GDE DROP WAS NOTICED TO BE BROKEN. NO CASE INVOLVED; THEREFORE, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11780624 ↗
• MalfunctionApr 26, 2021Break; Break

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION, IT WAS NOTICED THAT THE CLASP OF A 130 RAD DRILL GDE DROP FELL OF THE STAGE, CAUSING IT TO BREAK. NO SHRAPNEL FELL INTO THE PATIENT. NO PATIENT INJURY WAS REPORTED. THERE WAS A DELAY OF 30 MINUTES OR LESS AND IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11729572 ↗
• MalfunctionApr 22, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING SURGERY, WHILE USING THE 130 RAD DRILL GDE DROP, THE DRILL SLEEVE SEEMED TO BE RELEASING FROM THE LOCKED POSITION. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11711054 ↗
• MalfunctionApr 2, 2021Break; Break

  IT WAS REPORTED THAT, 130 RAD DRILL GDE DROP IS BROKEN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11610701 ↗

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