TRIGEN 71675081Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 03596010648600), received between Feb 24, 2019 and Jan 28, 2022 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT A CANNULATED IMPACTOR- MED BROKE AND GOT CROSS THREADED. IT IS UNKNOWN WHETHER THE EVENT HAPPENED RELATIVE TO THE SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13387506 ↗
• MalfunctionAug 25, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, A CANNULATED IMPACTOR- MED ENDED UP GETTING CROSS-THREADED INTO THE HFN DRILL GUIDE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12363868 ↗
• MalfunctionJun 22, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, AFTER A TRAUMA SURGERY, THE CANNULATED IMPACTOR- MED GOT STUCK INSIDE TWO (2) DRILL GUIDE HANDLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12042881 ↗
• MalfunctionJun 15, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT, A CANNULATED IMPACTOR- MED GOT STUCK IN DRILL GUIDE HANDLE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. AS THIS WAS NOTICED AFTER SURGERY, THE PATIENT WAS NO LONGER INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12000146 ↗
• MalfunctionJun 2, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A TRAINING SESSION THE THREAD OF A CANNULATED IMPACTOR- MED HAS ROUNDED OFF SO IT NEEDED TO BE TAKEN OUT OF CIRCULATION FOR REPLACEMENT. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11918378 ↗
• MalfunctionMay 20, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE CANNULATED IMPACTOR- MED WAS CROSS THREADED. IT IS UNKNOWN IF THERE WAS A SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11860085 ↗
• MalfunctionMay 6, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT AFTER PROCEDURE, IT WAS FOUND THAT THE CANNULATED IMPACTOR - SHORT AND THE CANNULATED IMPACTOR- MED WERE FUSED TOGETHER AND WILL NOT COME APART. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11784558 ↗
• MalfunctionApr 11, 2021Difficult to Remove; Mechanical Jam; Difficult to Remove; Mechanical Jam

  IT WAS REPORTED THAT, DURING SURGERY, WAS FOUND A CROSS THREADING OF THE IMPACTOR IN THE DRILL GUIDE HANDLE. AND WHILE TRYING TO REMOVE IMPACTOR SCREW BUSSING CAME AWAY FROM DRILL GUIDE HANDLE AND REMAINED STUCK ON IMPACTOR. INSTRUMENTS WERE OUTSIDE THE PATIENT. THERE WAS NO DELAY AND PROCEDURE WAS COMPLETED WITH THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646921 ↗
• MalfunctionFeb 21, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING USE, OUTSIDE THE PATIENT, THE IMPACTOR THREADS WERE DAMAGED AND WOULD NOT SCREW INTO THE DRILL GUIDE. THE PROCEDURE FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. NO SURGICAL DELAY. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11356770 ↗
• MalfunctionDec 8, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE CANNULATED IMPACTOR- MED AND THE DRILL GUIDE HANDLE THE THREADS ARE STRIPPED. NO CASE WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10972022 ↗
• MalfunctionOct 8, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT DURING SURGERY THE THREADS ON THE CANNULATED IMPACTOR- MED GOT STRIPPED. THERE WAS NO DELAY, AND A S&N BACK UP DEVICE FROM ANOTHER TRAY WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO INJURIES REPORTED AT THIS TIME. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10652621 ↗
• MalfunctionJan 21, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, DEVIDE BROKE DUE TO NORMAL WEAR AND TEAR. MALFUNCTIONED WITHIN THE PATIENT, ALL PIECES WERE REMOVED. NO DELAY AND NO INJURY REPORTED. BACKUP DEVICE AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9612488 ↗
• MalfunctionFeb 24, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE IMPACTOR BROKE IN DRILL GUIDE WHILST IMPACTING THE NAIL. NO DELAY WAS REPORTED A BACKUP DEVICE WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8364686 ↗

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