TRIGEN 71692803Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010648136), received between Apr 7, 2021 and Nov 22, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (1 report).

1 other recall cover devices cleared under the same FDA submission (K100107); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2021Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT, DURING SURGERY, A SS META SEMIEXTENDED DRILL GUIDE PROBE DISPLAYED ERROR MESSAGE INDICATING FAILURE WHILE IN USE. AFTER DISCONNECT AND CONNECT TO THE ANOTHER PROBE SENSOR PORT ON THE INTERFACE, IT WAS THE SAME. SURGERY WAS FINISHED WITH A BACK-UP DEVICE, WITH LESS THAN 5 MINUTES OF SURGICAL DELAY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12857785 ↗
• MalfunctionSep 29, 2021Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT, A SURESHOT MACHINE DISPLAYS AN ERROR MESSAGE, THE SS META SEMIEXTENDED DRILL GUIDE PROBE WAS CHANGED TO A NEW PROBE. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12545922 ↗
• InjuryApr 7, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING SURGERY, THE STAINLESS STEEL META SEMIEXTENDED DRILL GUIDE PROBE DID NOT WORK CORRECTLY. THE PROCEDURE WAS FINISHED WITH A CHANGE IN SURGICAL TECHNIQUE, USING THE RADIOLUCENT DRILL. THERE WAS A SURGICAL DELAY OF 10 MINUTES DUE TO THIS ISSUE. NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11627519 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100107. One submission often covers many models, so check the product and lot details in each record.

• Z-0411-2011 · Oct 15, 2010 · Terminated
  smith & nephew TRIGEN SURESHOT Distal Targeting System, Trauma Interface, V2.0.2, Trauma Launcher V1.01.1 Product is intended to be an intraoperative image-guided localization syst