TRIGEN 71631121Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 03596010497468), received between Sep 8, 2017 and Apr 20, 2026 — classified as 17 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Fracture” (20 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. 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2026Fracture

  IT WAS REPORTED THAT, DURING AN INTERTAN SURGERY, A HOLE WAS DRILLED INTO THE FEMORAL NECK TO INSERT THE SCREWS. DURING THIS STEP, THE 4.0MM LONG AO PILOT DRILL BROKE OFF, AND THE DRILL FRAGMENT REMAINED IN A HARD-TO-REACH LOCATION, MAKING IT IMPOSSIBLE TO REMOVE; THEREFORE, IT REMAINED INSIDE THE BONE. BEFORE THE DRILL BIT BROKE, WHEN INSERTING THE 10 MM NAIL, IT ADVANCED WITH DIFFICULTY. BECAUSE OF THIS, THE NAIL WAS REMOVED AND THE CANAL WAS RE-DRILLED. WHEN ATTEMPTING TO REINSERT THE NAIL, THE FEMUR FRACTURED AGAIN, THIS TIME BELOW THE LESSER TROCHANTER AND ABOVE THE INITIAL FRACTURE. THE NAIL WAS REMOVED, AND THE DOCTOR REQUESTED A THINNER 8.5 MM NAIL, WHICH WAS INSERTED. HOWEVER, THE DOCTOR THEN DECIDED TO REINSERT THE 10 MM NAIL. TO REINFORCE THE BONE, A CERCLAGE WAS PLACED, AND AN ADDITIONAL 3.5 MM SMITH PLATE WAS IMPLANTED. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. THE BROKEN FRAGMENT WAS NOT REMOVED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Bone Fracture(s)

  MAUDE report 24932445 ↗
• InjuryMar 14, 2026Fracture

  IT WAS REPORTED THAT, DURING AN INTRAMEDULLARY NAIL SURGERY, AFTER PLACING THE DRILLING CANNULAS AND DRILLING THE BONE, ONE (1) 4.0MM LONG AO PILOT DRILL TIP BROKE INSIDE THE PATIENT'S BONE, MAKING IT IMPOSSIBLE TO REMOVE THE FRAGMENT, AND THE BROKEN PART REMAINED IN THE PATIENT AS A LOST FIXATION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP.

  Patient problems: Foreign Body In Patient

  MAUDE report 24600311 ↗
• MalfunctionMar 10, 2026Fracture

  IT WAS REPORTED THAT DURING AN ANTEROGRADE FEMUR NAILING PROCEDURE, ONE (1) 4.0MM LONG AO PILOT DRILL BROKE IN THE GUIDE AT THE MOMENT OF LOCKING, NO FRAGMENTS INSIDE THE PATIENT. IT IS UNKNOWN HOW THE SURGERY WAS COMPLETED, BUT THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY. THE PATIENT WAS NOT INJURED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24560061 ↗
• InjuryFeb 16, 2026Fracture

  IT WAS REPORTED THAT DURING AN INTRAMEDULLARY META-TIBIA NAIL PROCEDURE, AFTER THE PLACEMENT OF THE NAIL AND CANNULA FOR DRILLING, THE 4.0MM LONG AO PILOT DRILL BIT BROKE IN THE PATIENT'S BONE DURING THE DRILLING PROCESS, LEAVING A FRAGMENT OF THE DRILL BIT IN THE PATIENT THAT COULD NOT BE REMOVED. THE BROKEN FRAGMENT COULD NOT BE REMOVED AND REMAINED AS A LOST FIXATION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP DEVICE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24351520 ↗
• MalfunctionJan 5, 2026Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, ONE (1) 4.0MM LONG AO PILOT DRILL BROKE WHILE DRILLING INTO THE PATIENT'S CORTICAL BONE. THE BROKEN PIECE WAS REMOVED FROM INSIDE THE PATIENT. 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 23969349 ↗
• MalfunctionNov 21, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE DRILL BIT OF ONE (1) 4.0MM LONG AO PILOT DRILL BROKE WHILE LOCKING THE SCREW; HOWEVER, IT WAS COMPLETELY REMOVED WITH FORCEPS. PATIENT WAS NOT HARMED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619096 ↗
• MalfunctionOct 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE PROXIMAL END OF ONE (1) 4.0 MM LONG AO PILOT DRILL FRACTURED AFTER THE SURGEON INCORRECTLY INSERTED THE DEVICE INTO THE DRILLING GUIDE. IT WAS MENTIONED THAT THE EVENT OCCURRED OUTSIDE THE PATIENT; THEREFORE, THE DRILL WAS NOT YET IN CONTACT WITH THE PATIENT. NO HARM WAS REPORTED. THE PROCEDURE WAS RESUMED WITHOUT DELAY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED; HOWEVER, NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23209976 ↗
• MalfunctionSep 8, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, ONE (1) 4.0MM LONG AO PILOT DRILL BIT FRACTURED DURING USE INSIDE THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS ANY DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22999776 ↗
• MalfunctionMar 17, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, ONE (1) 4.0MM LONG AO PILOT DRILL FELL OUT OF ITS NON-SEALED STERILE PACKET AFTER BEING OPENED AT THE SURGEON'S REQUEST. 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 21626136 ↗
• MalfunctionFeb 24, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE SEAL ON ONE (1) STERILE 4.0MM LONG AO PILOT DRILL PACKET WAS NOT SEALED. BREAKING INTEGRITY OF STERILITY. A S&N BACKUP DEVICE WAS AVAILABLE. SINCE THIS WAS NOTICED DURING SET UP OR INSPECTION PRIOR TO SURGERY, THE PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21445879 ↗
• InjuryJan 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING INTERNAL FIXATION SURGERY, ONE (1) 4.0MM LONG AO PILOT DRILL BROKE WHILE DRILLING FOR THE PROXIMAL SCREW, A SECOND (2) DRILL BIT FROM THE SET WAS USED AND ALSO BROKE. THE SURGEON THEN RESORTED TO A RECONSTRUCTION LOCKING SYSTEM. IT WAS NOTICED THAT THE DRILL BITS WERE HITTING THE NAIL AND CAUSING BREAKAGE. BOTH TIPS WERE NOT REMOVED FROM THE PATIENT. THE RECONSTRUCTION MODE WAS PERFORMED WITHOUT PROBLEMS AND THE CASE WAS COMPLETED. IT IS UNKNOWN HOW WAS COMPLETED AND IF THERE WAS ANY DELAY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21157934 ↗
• InjuryJan 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING INTERNAL FIXATION SURGERY, ONE (1) 4.0MM LONG AO PILOT DRILL BROKE WHILE DRILLING FOR THE PROXIMAL SCREW. THE SURGEON THEN RESORTED TO A RECONSTRUCTION LOCKING SYSTEM. IT WAS NOTICED THAT THE DRILL BIT WAS HITTING THE NAIL AND CAUSING BREAKAGE. THE TIP NOT REMOVED FROM THE PATIENT. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21157859 ↗
• MalfunctionJan 3, 2025Break; Break

  IT WAS REPORTED THAT DURING A FEMORAL NAIL PROCEDURE, WHILE DRILLING INTO THE BONE TO SECURE IT WITH A SCREW, ONE (1) 4.0MM LONG AO PILOT DRILL BROKE, IT WAS QUICKLY REMOVED. 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 21067291 ↗
• MalfunctionNov 6, 2024Break; Break

  IT WAS REPORTED THAT, DURING A FEMUR OSTEOSYNTHESIS, THE DOCTOR FORCED ONE (1) 4.0MM LONG AO PILOT DRILL AND IT BENT. DOCTOR TRIED TO STRAIGHTEN IT, BUT IT BROKE, INSTEAD. 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 20620878 ↗
• MalfunctionAug 27, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY (FEMORAL OSTEOTOMY), WHEN DRILLING INTO PATIENT'S SECOND CORTICAL BONE, ONE (1) 4.0MM LONG AO PILOT DRILL BROKE. THE DEVICE WAS COMPLETELY REMOVED. 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 20081601 ↗
• MalfunctionJul 2, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY DUE TO A FRACTURE OF THE RIGHT FEMUR, WHEN PASSING THE GUIDE, IT HIT THE SHAFT AND BROKEN IT. WHEN DRILLING THE STERILE 6.4MM DRILL, IT HIT THE ROD AND ENDED UP BREAKING. THE POSITION WAS LATERAL DECUBITIS, THE DRILL TIP WAS NOT REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO FURTHER INFORMATION AVAILABLE AT THE MOMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19656721 ↗
• MalfunctionApr 26, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING TIBIAL OSTEOTOMY, ONE (1) 4.0MM LONG AO PILOT DRILL BROKE DURING DRILLING. PIECES WERE REMOVED WITH AN INSTRUMENT. 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 19192638 ↗
• MalfunctionMar 13, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A FEMUR STEM PROCEDURE, WHEN DRILLING THE BONE TO PASS THE SCREW, ONE (1) 4.0MM LONG AO PILOT DRILL BROKE. ALL PIECES WERE RECOVERED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY (10 MIN), WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18896233 ↗
• MalfunctionSep 14, 2023Fracture; Fracture

  IT WAS REPORTABLE THAT DURING A TIBIAL OSTEOSYNTHESIS, THE 4.0MM LONG AO PILOT DRILL BROKE WHEN HITTING THE ROD. THE TIP OF THE DRILL WAS REMOVED WITH TWEEZERS. 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 17744432 ↗
• InjuryJun 26, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AT THE TIME OF DRILLING THE FEMUR DURING A FEMUR FRACTURE REDUCTION SURGERY WITH AN INTERTAN NAIL, A 4.0MM LONG AO PILOT DRILL COLLIDED WITH THE NAIL AND BROKE INSIDE THE PATIENT'S BONE. IT WAS NOT POSSIBLE TO REMOVE THE PART OF THE DRILL BIT THAT BROKE INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY. PATIENT CURRENT HEALTH IS STABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17199740 ↗
• InjuryJun 11, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, WHEN PERFORMING THE PROXIMAL LOCKING OF THE NAIL, THE SURGEON MADE A SUDDEN MOVEMENT WHEN REMOVING THE 4.0MM LONG AO PILOT DRILL FROM THE NEEDLE. IT WAS NOTICED THAT IT HAD BROKEN AND A PIECE REMAINED INSIDE THE PATIENT. THE SPECIALIST TRIED TO REMOVE THE PART OF THE DRILL BIT THAT REMAINED IN THE BONE, BUT WHEN HE REALIZED THAT IT WAS NOT POSSIBLE IN A SIMPLE WAY, DECIDED TO LEAVE IT INSIDE THE PATIENT'S BONE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17102357 ↗
• MalfunctionApr 11, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING TIBIAL FIXATION FRACTURE SURGERY, ONE 1 4.0MM LONG AO PILOT DRILL BROKE WHILE DRILLING THROUGH THE BONE FOR PLACEMENT OF THE LOCKING SCREW. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. HOWEVER NO SURGERY DELAYS OR PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16717798 ↗
• InjuryNov 21, 2022Fracture; Off-Label Use; Fracture; Off-Label Use

  IT WAS REPORTED THAT, DURING THE OSTEOSYNTHESIS PROCEDURE OF THE FEMUR, THE 4.0MM LONG AO PILOT DRILL BROKE BECAUSE IT WAS INCORRECTLY ANGULATED. ALL PIECES WERE REMOVED. THE PRODUCT WAS NOT USED ACCORDING TO THE INSTRUCTIONS FOR USE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. THE PATIENT'S HEALTH CONDITION IS STABLE. 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 15839150 ↗
• InjuryMar 11, 2022Break; Break

  IT WAS REPORTED THAT, DURING INTRAMEDULLARY NAIL PROCEDURE, ONCE THE NAIL IS IMPLANTED INSIDE THE FEMUR, IT WAS NOT POSSIBLE TO FIT THE LONG AO PILOT DRILL BITS INTO THE NAIL. THE DRILL WAS DRILLED INTO THE BONE ONE LAST TIME AND WHEN THE DRILL WAS REMOVED WE NOTICED THAT IT WAS BROKEN, LEAVING A PART INSIDE THE PATIENT'S BONE. PROCEDURE WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, BY PLACE THE CONVENTIONAL NAIL LOCK (TROCHANTERIC) WITH A BACK-UP DEVICE. PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13734126 ↗
• InjuryNov 17, 2021Break; Break

  IT WAS REPORTED THAT DURING AN INTERTAN FEMORAL NAILING, THE TIP OF A 4.0MM LONG AO PILOT DRILL BROKE, AND IT COULD NOT BE REMOVED FROM PATIENT'S BONE. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT DELAY, USING A SMITH AND NEPHEW BACK UP DEVICE. PATIENT STATUS IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 12828490 ↗