TRIGEN 71631110Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010392503), received between Apr 3, 2019 and Feb 10, 2026 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2026Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY , WHILE USING ONE (1) 4.0MM LONG PILOT DRILL TO DRILL THE DISTAL LATERAL LOCKING DEVICE, THE DRILL BIT BROKE INSIDE THE PATIENT. THE BROKEN PIECE COULD NOT BE REMOVED AND IS FUNCTIONING AS A SCREW. THE PROCEDURE WAS PERFORMED, AFTER A SIGNIFICANT DELAY, USING THE SAME DEVICE. NO CONSEQUENCES HAVE BEEN REPORTED AS A RESULT OF THIS EVENT SO FAR. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24310471 ↗
• InjuryOct 2, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A NAIL PROCEDURE, A PIECE OF ONE (1) 4.0MM LONG PILOT DRILL BROKE OFF AND WAS IRRETRIEVABLE. THE PIECE STILL REMAINS INSIDE THE PATIENT. PATIENTS' CURRENT HEALTH STATUS IS UNKNOW.

  Patient problems: Foreign Body In Patient

  MAUDE report 17852067 ↗
• MalfunctionApr 2, 2021Unstable; Material Twisted/Bent; Unstable; Material Twisted/Bent

  IT WAS REPORTED THAT 4.0 MM LONG PILOT DRILL MOVED ROUGHLY (OUT OF CENTER AXIS). USING A SMITH AND NEPHEW BACK UP DEVICE, THE SURGERY WAS COMPLETED. NO HARM TO PATIENT. NO DELAY.THE INVESTIGATION FOUND THAT THE DRILL IS BENT, WHICH MAKES IT A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11609530 ↗
• InjuryMar 1, 2021Break; Break

  IT WAS REPORTED THAT THE DRILL BIT BROKE DURING SURGERY. SURGICAL DELAY MORE THAN 30 MINUTES. UNKNOWN HOW THE PROCEDURE FINISHED. PATIENT INJURIES WERE NOT REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11391141 ↗
• InjuryMar 1, 2021Break; Break

  IT WAS REPORTED THAT THE DRILL BIT BROKE DURING SURGERY, INSIDE THE PATIENT. SURGICAL DELAY MORE THAN 30 MINUTES. THE PROCEDURE FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. PATIENT INJURIES WERE NOT 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 11391140 ↗
• MalfunctionMay 27, 2019Component Missing; Component Missing

  IT WAS REPORTED THAT DURING SURGERY THE DRILL BIT WAS MISSING FROM THE SET. MORE THAN 30 MINUTES DELAY WAS REPORTED AND THE PROCEDURE WAS FINISHED WITH A COMPETITORS DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8643499 ↗
• MalfunctionApr 3, 2019Break; Break

  IT WAS REPORTED THAT DURING CASE THE DRILL BROKE. ALL PIECES ACCOUNTED FOR. NO DELAY REPORTED. NO INJURY REPORTED. A SMITH AND NEPHEW BACK UP WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8480172 ↗