TRIGEN 71674071Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03596010560643), received between Nov 26, 2018 and Sep 28, 2021 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K122170); 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. 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING TRAUMA SURGERY, THE SURGEON WAS UNABLE TO UNSCREW A TRIGEN 7/16 GUIDE BOLT AND REMOVE THE ALIGNMENT DRILL GUIDE. EXCESSIVE FORCE WAS USED TO LOOSEN THE TRIGEN 7/16 GUIDE BOLT, WHICH LED TO BREAKAGE OF A TRIGEN GUIDE BOLT WRENCH. THE TIP OF THE TRIGEN GUIDE BOLT WRENCH GOT STUCK INSIDE THE TRIGEN 7/16 GUIDE BOLT. THE ISSUE WAS SOLVED BY DRILLING A HOLE THROUGH THE TRIGEN 7/16 GUIDE BOLT WITH A METAL BUR. THE ALIGNMENT GUIDE WAS REMOVED WITH A BACK-UP GUIDE BOLT WRENCH. A SIGNIFICANT DELAY WAS CAUSED AS CONSEQUENCE OF THIS PROBLEM. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12543934 ↗
• MalfunctionSep 10, 2021Failure to Align; Material Deformation; Failure to Align; Material Deformation

  IT WAS REPORTED THAT A DRILL GUIDE HANDLE IS WARPED AND ITS TARGETING IS OFF AND THAT A 7/16 GUIDE BOLT IS CROSS-THREADED AND DOES NOT ATTACH PROPERLY. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12456448 ↗
• MalfunctionAug 11, 2021Failure to Align; Failure to Align

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE DISTAL SCREW HOLES DID NOT ALIGN PROPERLY. IT IS UNKNOWN IF THE 7/16 GUIDE BOLT, 125 RAD DRILL GDE DROP, 130 RAD DRILL GDE DROP OR DRILL GUIDE HANDLE CAUSED THE MISALIGNMENT. PROCEDURE WAS COMPLETED WITH A BACK-UP DEVICE WITHOUT ANY DELAY. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12307696 ↗
• MalfunctionMay 24, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING NAIL CASE, THE 7/16 GUIDE BOLT WAS STRIPPED. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. NO INJURY TO PATIENT OR DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11871833 ↗
• MalfunctionApr 28, 2021Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT AFTER AN INTERTAN NAIL INSERTION PROCEDURE, IT WAS NOTICED THAT THE 7/16 GUIDE BOLT THREADS ARE WEARING AND BREAKING DOWN. THIS INCIDENT WAS REALIZED AFTER THE PROCEDURE; HENCE, SURGERY WAS COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11742454 ↗
• InjuryApr 21, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING SURGERY, THE TIP 7/16 GUIDE BOLT CROSS-THREADED INTO THE NAIL RESULTING IN NOT BEING ABLE TO RELEASE THE NAIL FROM THE INTERTAN DRILL GUIDE. SURGERY WAS COMPLETED BY USING A COMPETITOR DEVICE. SURGERY WAS NOT SIGNIFICANTLY DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11699934 ↗
• MalfunctionMar 24, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE END OF THE 7/16 GUIDE BOLT WHICH IS TIGHTENED USING A GUIDE BOLT WRENCH IS WORN INTO A CIRCLE INSTEAD OF A HEXAGONAL SHAPE, SO THE WRENCH DOESN'T NOT CATCH TO TIGHTEN THE BOLT. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11566422 ↗
• MalfunctionMar 19, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SURGERY, THE 7/16 GUIDE BOLT WAS NOT LOCKING INTO THE IMPLANT. PROCEDURE CONTINUED USING A BACKUP DEVICE FROM SMITH AND NEPHEW, WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES AND NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11522600 ↗
• MalfunctionNov 24, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE GUIDE BOLT HEAD WAS STRIPPED. THIS CAUSED A DELAY BETWEEN 0-30 MIN AND IT WAS NECESSARY TO USED A BACKUP FROM SMITH & NEPHEW TO FINISH THE SURGERY. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10892350 ↗
• MalfunctionNov 5, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT IN A 7/16 GUIDE BOLT, THREADS ARE STRIPPED. NO HARM OR INJURY REPORTED ON PATIENT. PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO DELAY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10791087 ↗
• MalfunctionNov 26, 2018Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE GUIDE BOLT WRENCH HEAD SNAPPED OFF INSIDE THE GUIDE BOLT. ALL PIECES ACCOUNTED FOR. DELAY OF OVER 2 HOURS REPORTED. NO INJURY REPORTED. PROCEDURE FINISHED WITH COMPETITOR DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8104357 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122170. One submission often covers many models, so check the product and lot details in each record.

• Z-0351-2020 · Oct 7, 2019 · Terminated
  LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN nails are indicated for fractures of the femur including: simple shaft fractures, comminuted sha