TRIGEN 71674081Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03596010560780), received between Nov 13, 2020 and May 24, 2021 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (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 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.

• MalfunctionMay 24, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, IT WAS NOTICED THAT THE THREADS OF AN IMPACTOR WERE CROSS THREADED. THERE WAS NO 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 11872881 ↗
• MalfunctionMay 20, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, DURING SET UP FOR AN IM NAIL SURGERY, A IMPACTOR (71674081) WAS FOUND SHEERED (B)(4), PARTS OF IT WERE FOUND IN THE TAN/FAN PERC DRILL GUIDE (71631021); HENCE, IT COULD NOT BE USED (B)(4). PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, BY USING A BACK-UP DEVICE. PATIENT WAS NOT IMPACTED BY THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11860075 ↗
• MalfunctionApr 28, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT, DURING IM NAIL SURGERY, THE THREADS ON THE IMPACTOR WAS FOUND TO BE WORN. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11742494 ↗
• MalfunctionApr 26, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING INSPECTION THESE DEVICES WERE FOUND WITH AN ISSUE. DRILL GUIDE HANDLE (CASE: (B)(4)), AND IMPACTOR (CASE: (B)(4)) WERE FOUND WITH DAMAGED THREADS AND DO NOT SCREW TOGETHER PROPERLY. THE SHORT HEXDRIVER (CASE: (B)(4)) WAS FOUND WITH THE CONNECTER END BROKEN. THE INTERTAN 3.2MM GUIIDE PIN SLEEVE (CASE: (B)(4)) DID NOT ENTER A SLEEVE PROPERLY AND THE 12.5MM ENTRY REAMER (CASE: (B)(4)) HAD NICKS AND CUTS. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11729575 ↗
• MalfunctionFeb 21, 2021Break; Break

  IT WAS REPORTED THAT, DURING TRAUMA SURGERY THE BOLT PORTION OF THE IMPACTOR BROKE OUTSIDE OF THE PATIENT. NO DELAY WAS REPORTED. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11356735 ↗
• InjuryJan 6, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE THE IMPACTOR BREAK, INSTRUMENTS INSIDE THE PATIENT. IT IS UNKNOWN IF THERE WAS A DELAY OR HOW THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11124353 ↗
• MalfunctionDec 31, 2020Break; Break

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE IMPACTOR BROKE. INSTRUMENTS OUTSIDE OF PATIENT. S&N BACKUP DEVICE AVAILABLE. NO SURGICAL DELAY OR INJURY TO PATIENT REPORTED DUE THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11102294 ↗
• MalfunctionDec 16, 2020Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT DURING SET UP, THE IMPACTOR THREADS WERE FOUND DAMAGED. THERE WAS NO DELAY NOR INJURY REPORTED. A S&N BACKUP DEVICE WAS AVAILABLE DURING THE PROCEDURE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11020072 ↗
• MalfunctionNov 18, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT THE IMPACTOR WAS FOUND DEFECTIVE. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10864646 ↗
• MalfunctionNov 16, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING PROCEDURE AND OUTSIDE THE PATIENT IT WAS NOTICED THAT THE IMPACTOR FROM THE TRIGEN BASE DID NOT CONNECT TO THE DRILL GUIDE HANDLE BECAUSE THE THREADS ON THE SCREW IN PART WERE DAMAGED. IT IS NOT KNOWN HOW THE PROCEDURE WAS COMPLETED. NO INJURIES OR SURGICAL DELAYS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10848802 ↗
• MalfunctionNov 13, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE IT WAS FOUND THAT THE IMPACTOR THREADS ARE WORN. INSTRUMENT INSIDE PATIENT. PROCEDURE FINISHED WITH SAME DEVICE. NO SURGICAL DELAY OR INJURY TO PATIENT REPORTED DUE THIS EVENT. 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 10836763 ↗

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