TRIGEN 71631035Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010605962), received between May 19, 2017 and Nov 26, 2025 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTRAMEDULLARY NAILING PROCEDURE, DUE TO THE PATIENT'S BONE BEING VERY RIGID AND DENSE, ONE (1) STERILE 6.4 MM DRILL BROKE DURING REAMING. THE BROKEN PIECES WERE COMPLETELY REMOVED WITH FORCEPS. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657145 ↗
• InjuryJul 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 DECUBITION, 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 19656447 ↗
• InjuryMar 23, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INSERTION OF A LEFT FEMORAL INTRAMEDULLARY NAIL, THE STERILE 6.4MM DRILL BIT BROKE OFF IN THE LEFT FEMORAL NECK. APPROXIMATELY 3.5CM OF THE DRILL BIT REMAINS IN THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. NO OTHER INJURY WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16607477 ↗
• InjuryOct 13, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE DRILL BIT STERILE 6.4MM DRILL BROKE. THE PHYSICIAN FELT THE DRILL BIT BROKE WITHOUT ANY PREVIOUS RESISTANCE. ALSO, ATTEMPTED TO RETRIEVE THE DRILL BIT TIP, BUT WAS NOT POSSIBLE. SINCE THE NAIL HAD VERY STABLE FIXATION DECIDED TO TAKE ADVANTAGE OF IT AND LEAVE IT AS IS. SURGERY WAS RESUMED, WITH A GREATER 60 MINUTES DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: Foreign Body In Patient

  MAUDE report 12624239 ↗
• MalfunctionMar 30, 2021Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, WHILE USING A STERILE 6.4 MM DRILL, THE TIP OF THE DRILL BROKE. NO INJURY WAS DONE TO THE PATIENT. THE OPERATION COMPLETED SUCCESSFULLY. NO OTHER COMPLICATIONS WERE REPORTED. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED AND IF THERE WAS ANY SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593381 ↗
• InjuryJan 4, 2021Break; Break

  IT WAS REPORTED THAT DURING A TRIGEN TAN NAIL CASE, WHILE DRILLING WITH 6.4MM DRILL BIT, THE TIP OF DRILL BIT (APPROX 3CM) BROKE OFF IN THE NECK OF THE PATIENT'S FEMUR. BROKEN PIECE OF DRILL WAS UNABLE TO BE RETRIEVED. UNABLE TO IMPLANT 2ND RECON SCREW. DELAY REPORTED GREATER THAN 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11108670 ↗
• MalfunctionOct 9, 2020Break; Break

  IT WAS REPORTED THAT DURING ARTHROSCOPY (ACL OR OTHER) WHILE INSTRUMENT WAS OUTSIDE THE PATIENT THE STERILE 6.4MM DRILL BROKE. DELAY REPORTED LESS OR EQUAL THAN 30 MINUTES. IT IS UNKNOWN HOW WAS THE PROCEDURE COMPLETED. NO REPORT OF PATIENT INJURY OR HARM WAS RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10657178 ↗
• MalfunctionSep 10, 2020Break; Break

  IT WAS REPORTED THAT, AFTER SURGERY, WAS NOTICED THAT THE STERILE 6.4MM DRILL HEAD IS WORN AND CHIPPED AND CAN NO LONGER BE USED. THERE WAS NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10516457 ↗
• InjuryMay 19, 2017Break

  IT WAS REPORTED THAT DURING SURGERY, THE FEMORAL NECK OF THE DRILL BROKE. IN ORDER TO CONTINUE SURGERY, THE PRIMARY NAIL AND FEMORAL NECK HAD TO BE REMOVED, WHICH RESULTED IN A 60 MINUTES DELAY IN SURGERY.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 6577975 ↗