TRIGEN 71692810Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010648242), received between Jun 14, 2018 and Mar 13, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING TRIGEN META NAIL TIBIA PROCEDURE WHILE DRILLING A DISTAL A/P HOLE, THE DEVICE COULD DRILL THE CORTICAL ON THE NEAR SIDE, BUT COULD NOT PENETRATE TO THE OPPOSITE CORTICAL. THE SURGEON DECIDED TO USE A RADIOLUCENT DRILL TO COMPLETE THE PROCEDURE, MOREOVER, SURGERY WAS DELAYED FOR NO MORE THAN 30 MIN. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9831257 ↗
• InjuryJun 14, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING SURGERY THE SURGEON INSERTED THE DRILL AT THE DISTAL NAIL ML SCREW HOLE AND THE DRILL WAS INTERFERING WITH THE NAIL, SO THE SURGEON STOPPED DRILLING AND REMOVED THE DRILL, THEN HE FOUND THAT SOMETHING BLACK HAD BEEN ATTACHED TO THE DRILL. THE SURGEON HAD TO DRILLED BY HAND AND INSERTED THE SCREW.

  Patient problems: No Information

  MAUDE report 7603775 ↗

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