INTERTAN 71934690Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00885556266441), received between Jun 30, 2020 and Feb 18, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN INTERTROCH FEMUR FRACTURE SURGERY, AN INTERTAN DRILL GUIDE EXTENDED IS CONSTANTLY MISSING THE NAIL. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN THE SURGICAL TECHNIQUE. NO ADDITIONAL ANESTHESIA WAS REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377035 ↗
• MalfunctionMay 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE THREADED METAL INSERT CAME OUT OF ONE (1) INTERTAN DRILL GUIDE EXTENDED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22019562 ↗
• MalfunctionDec 12, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING AN ORIF SURGERY, ONE (1) INTERTAN DRILL GUIDE EXTENDED WAS BENT SO IT MISSED THE DISTAL TARGETED SCREW HOLE, RESULTING IN AN UNPLANNED HOLE. THE PROCEDURE WAS COMPLETED WITH A CHANGE IN SURGICAL TECHNIQUE USING PERFECT CIRCLES TO TARGET THE DISTAL HOLE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. NO INJURY HAS BEEN REPORTED AS A RESULT.

  Patient problems: Perforation

  MAUDE report 20913127 ↗
• MalfunctionDec 12, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING AN ORIF SURGERY, ONE (1) INTERSTRAIN DRILL GUIDE EXTENDED WAS BENT SO IT MISSED THE DISTAL TARGETED SCREW HOLE, RESULTING IN AN UNPLANNED HOLE. THE PROCEDURE WAS COMPLETED WITH A CHANGE IN SURGICAL TECHNIQUE USING PERFECT CIRCLES TO TARGET THE DISTAL HOLE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. NO INJURY HAS BEEN REPORTED AS A RESULT.

  Patient problems: Perforation

  MAUDE report 20912910 ↗
• MalfunctionDec 4, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING AN ORIF SURGERY, ONE (1) INTERTAN DRILL GUIDE EXTENDED WAS BENT SO IT MISSED THE DISTAL TARGETED SCREW HOLE, RESULTING IN AN UNPLANNED HOLE. THIS PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY WITH A CHANGE IN SURGICAL TECHNIQUE, USING PERFECT CIRCLES TO TARGET THE DISTAL HOLE. NO OTHER INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: Perforation

  MAUDE report 20844851 ↗
• MalfunctionMar 15, 2024Fracture; Separation Failure; Fracture; Separation Failure

  IT WAS REPORTED THAT DURING SURGERY ONE (1) EXTENDED GUIDE BOLT WAS CROSS THREADED ONTO THE NAIL THROUGH ONE (1) INTERTAN DRILL GUIDE EXTENDED AND IT WAS NOT POSSIBLE TO REMOVE THE BOLT FROM THE NAIL. IT SEEMS THE INSTRUMENT FRACTURED OFF DUE TO THIS PROBLEM. IT IS UNKNOWN IF PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MIN, WITH AN UNSPECIFIED CHANGE IN SURGICAL TECHNIQUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18915217 ↗
• MalfunctionMay 24, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING SURGERY, IT WAS NOTICED THAT THE THREADS OF THE INTERTAN DRILL GUIDE EXTENDED ARE CROSS THREADED. DEVICE OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11872872 ↗
• MalfunctionApr 26, 2021Crack; Crack

  IT WAS REPORTED THAT, THE X-RAY LINE ON THE INTERTAN DRILL GUIDE EXTENDED WAS CRACKED. AS THIS WAS NOTICED AFTER SURGERY WHEN REPROCESSING TRAYS, THE PATIENT WAS NO LONGER INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11729590 ↗
• MalfunctionApr 20, 2021Crack; Peeled/Delaminated; Crack; Peeled/Delaminated

  IT WAS REPORTED THAT DURING A ROUTINE INSPECTION THE INTERTAN DRILL GUIDE EXTENDED WAS PEELED AND CRACKED. NO CASE WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11693217 ↗
• MalfunctionJun 30, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING INSPECTION, IT WAS NOTICED THAT THE THREADED SLEEVE, WHERE THE IMPACTOR GOES IN, MAY BE STRIPPED OR CROSS THREADED. NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10216154 ↗

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