TRIGEN 71631123Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 03596010497475), received between May 25, 2020 and May 3, 2026 — classified as 21 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Fracture” (40 reports).

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 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 3, 2026Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, AFTER DRILLING THE SCREW HOLE, ONE (1) 4.0MM SHORT AO PILOT DRILL BROKE WHILE TRYING TO REMOVE IT. IT WAS REMOVED THROUGH THE INCISION ITSELF USING A KELY. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25064272 ↗
• MalfunctionMar 14, 2026Fracture

  IT WAS REPORTED THAT, DURING AN INTRAMEDULLARY NAIL SURGERY, WHILE PERFORMING DISTAL ROD LOCKING FREEHAND USING ONE (1) 4.0MM SHORT AO PILOT DRILL, IT EXPERIENCED FRICTION AGAINST THE BONE AND BROKE, THE PIECES WERE REMOVED WITH PLIERS, AND IT WAS REQUIRED TO USE THE LONG DRILL BIT INSTEAD. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP.

  Patient problems: Foreign Body In Patient

  MAUDE report 24600305 ↗
• MalfunctionFeb 2, 2026Fracture

  IT WAS REPORTED THAT, DURING A TIBIAL OSTEOTOMY SURGERY, WHILE DRILLING THE TIBIAL CORTEX THE DRILL BIT OF ONE (1) 4.0MM SHORT AO PILOT DRILL BROKE. THE FRAGMENT WAS REMOVED WITH FORCEPS. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24233656 ↗
• MalfunctionJan 23, 2026Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, WHILE DRILLING THE DISTAL TIBIAL LOCKING HOLE, ONE (1) 4.0MM SHORT AO PILOT DRILL BROKE. THE BROKEN DRILL BIT WAS REMOVED WITHOUT FRAGMENTS USING SURGICAL FROCEPS. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO HARM TO THE PATIENT NOR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24161245 ↗
• MalfunctionJan 14, 2026Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, WHILE PERFORMING THE DISTAL LOCKING PROCEDURE USING THE FREEHAND METHOD, THE 4.0MM SHORT AO PILOT DRILL BROKE WHILE LOCKING THE LAST SCREW. BREAKAGE OCCURRED WITHIN THE PATIENT AND THE PHYSICIAN REMOVED WITH KELLY CLAMP. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24075514 ↗
• MalfunctionDec 11, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A FEMORAL NAILING PROCEDURE, WHILE DRILLING THE BONE TO LOCK THE NAIL THE 4.0MM SHORT AO PILOT DRILL BROKE, AND IT WAS REMOVED WITH KELLY FORCEPS. 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 23784325 ↗
• MalfunctionDec 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TRAUMA 03 META-TIBIA INTRAMEDULLARY NAIL PROCEDURE WHILE BEING USED ON THE PATIENT¿S BONE WITH THE DRILL BIT PROPERLY MOUNTED IN THE DRILL, THE DRILL BIT BROKE LEAVING ONE FRAGMENT IN THE BONE AND ANOTHER IN THE DRILL, WHICH WAS LATER REMOVED WITH PLIERS, THE PROCEDURE WAS RESUMED WITHOUT SURGICAL DELAY USING THE SAME DEVICE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693951 ↗
• MalfunctionDec 1, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A FEMORAL OSTEOSYNTHESIS PROCEDURE, THE SURGEON BROKE ONE (1) 4.0MM SHORT AO PILOT DRILL WHILE PERFORMING DISTAL ROD LOCKING. THE BROKEN DRILL TIP REMAINED INSIDE THE PATIENT BUT WAS SUBSEQUENTLY REMOVED USING PLIERS. THE PROCEDURE WAS COMPLETED, AFTER NO DELAY, USING AN EQUIVALENT S+N BACK UP. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23687340 ↗
• MalfunctionNov 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TIBIAL NAILING SURGERY, ONE (1) 4.0MM SHORT AO PILOT DRILL BROKE. THE BROKEN PIECES WERE REMOVED WITH TWEEZERS. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED; HOWEVER, THERE WAS NO DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23451600 ↗
• MalfunctionOct 20, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A RETROGRADE INTRAMEDULLARY NAIL SURGERY IN THE FEMORAL METACARPAL BONE, ONE (1) 4.0MM SHORT AO PILOT DRILL BROKE UPON INITIALIZING THE ENTRY POINT. THE 4.0MM SHORT AO PILOT DRILL WAS REMOVED USING FORCEPS. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO INJURIES WERE REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23337109 ↗
• MalfunctionSep 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT, BEFORE STARTING AN INTERNAL FIXATION SURGERY ONE (1) 4.0MM SHORT AO PILOT DRILL BROKE WHILE DRILLING THE BONE CORTEX. THE MATERIAL WAS COMPLETELY REMOVED FROM THE PATIENT USING SURGICAL FORCEPS. 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 23163868 ↗
• InjuryJul 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TIBIAL OSTEOTOMY PROCEDURE ON (B)(6) 2025, THE DRILL BIT THAT WAS USED FRACTURED WHILE DRILLING THE SECOND BLOCK AND COULD NOT BE REMOVED. THE BROKEN DRILL BIT REMAINED INSIDE THE PATIENT. THE INCIDENT DID NOT RESULT IN A PROCEDURAL DELAY, AND NO ADDITIONAL CLINICAL IMPACT WAS REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 22661508 ↗
• MalfunctionJul 9, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN INTERTAN FEMORAL RODDING, WHEN THE NURSE WENT TO OPEN THE PACKAGE OF ONE (1) 4.0MM SHORT AO PILOT DRILL TO GIVE TO THE TECH, THERE WAS A CLEAR ABRASION IN THE PACKAGING BREAKING STERILE. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. SINCE INCIDENT OCCURRED BEFORE PROCEDURE; PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22465137 ↗
• InjuryMay 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE SURGEON USED A SLIGHT ANGLE WHEN DRILLING INTO THE TIBIA, CAUSING ONE (1) 4.0MM SHORT AO PILOT DRILL TO BREAK. THE SURGEON WAS UNABLE TO REMOVE THE FRAGMENT AS IT WAS FIRMLY EMBEDDED IN THE PATIENT'S BONE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 21991044 ↗
• InjuryApr 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY FOR A FRACTURE OF THE PROXIMAL FEMUR, THE SURGEON FOLLOWED THE CORRECT INSTRUCTIONS WHEN USING ONE (1) 4.0MM SHORT AO PILOT DRILL; HOWEVER, THE DRILL BROKE, LEAVING A PIECE INSIDE THE PATIENT. THE SURGEON WAS UNABLE TO REMOVE THE FRAGMENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21933657 ↗
• MalfunctionMar 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, ONE (1) 4.0MM SHORT AO PILOT DRILL BROKE WHILE DRILLING THE DISTAL BLOCK. THE DRILL BIT ENDED UP FORCING AGAINST THE ROD, WHICH CAUSED THE TIP TO BREAK. THE BROKEN PIECE WAS REMOVED WITH THE HELP OF A NEEDLE HOLDER. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, 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 21689397 ↗
• MalfunctionMar 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TIBIAL NAIL PROCEDURE, A (1) 4.0MM SHORT AO PILOT DRILL BROKE WHILE DRILLING FOR THE DISTAL BLOCK. THE BROKEN PIECES WERE SUCCESSFULLY REMOVED WITH A KELLY CLAMP. THE PROCEDURE WAS RESUMED, AFTER NO DELAY, WITH THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21532151 ↗
• MalfunctionMar 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TIBIAL OSTEOTOMY PROCEDURE, ONE (1) 4.0MM SHORT AO PILOT DRILL BROKE. THE DEVICE WAS RETRIEVED USING FORCEPS. 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 21504555 ↗
• InjuryDec 20, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION PROCEDURE, THE TIP OF A 4.0MM SHORT AO PILOT DRILL BROKE OFF AND WAS LEFT INSIDE PATIENTS BONE. SURGEON DOES NOT FAULT THE PRODUCT OR BELIEVE IT HAD A DEFECT. IT BROKE BECAUSE IT WAS BEING USED TO DRILL THROUGH A PLATE AND THE NAIL AND THIS FLEXED THE TIP CAUSING IT TO BREAK. PATIENT WAS INFORMED THAT NO COMPLICATION WOULD BE EXPECTED. THE PROCEDURE WAS COMPLETED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20995867 ↗
• MalfunctionOct 17, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, WHEN DRILLING THE PROXIMAL BLOCK OF THE NAIL, THE 4.0MM SHORT AO PILOT DRILL BROKE. IT WAS COMPLETELY REMOVED FROM THE PATIENT, POSING NO HEALTH RISK. 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 20477842 ↗
• MalfunctionSep 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A FEMUR NAILING PROCEDURE, TWO (2) 4.0MM SHORT AO PILOT DRILL BROKE WHILE SURGEON WAS TRYING TO DRILL PATIENT'S BONE. IT IS UNKNOWN HOW PIECES WERE RETRIEVED. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20156530 ↗
• MalfunctionJun 4, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, TWO (2) 4.0MM SHORT AO PILOT DRILLS WERE BENT. ADDITIONALLY, 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 19464127 ↗
• MalfunctionMay 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, WHILE DRILLING, ONE (1) 4.0MM SHORT AO PILOT DRILL FRACTURED. A PIECE FELL INTO THE PATIENT AND WAS RETRIEVED BY HAND USING A BAG. 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 19336623 ↗
• MalfunctionMay 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY IN THE RIGHT FEMUR, WHEN DRILLING A 4.0MM SHORT AO PILOT DRILL BROKE. THE SMALLER PIECES WERE RETRIEVED WITH THE AID OF PLIERS. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO DAMAGES TO THE PATIENT'S HEALTH WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19248748 ↗
• MalfunctionMay 2, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TIBIAL OSTEOTOMY PROCEDURE, WHEN DRIVING THE DISTAL ROLE HOLE, DRIVING THE SECOND CORTICAL OF THE BONE, THE 4.0MM SHORT AO PILOT DRILL BROKE. IT IS UNKNOWN IF BROKEN PIECES FELL INSIDE THE PATIENT. 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 19231946 ↗