TRIGEN 71674080Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 03596010560766), received between Aug 11, 2017 and Sep 12, 2024 — classified as 6 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Break” (13 reports).

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 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, THE SPRING MECHANISM TO CONTROL GRIPPING OF THE WIRE, OF A GRIPPER BROKE. THE PROCEDURE WAS PERFORMED, USING A S+N BACK-UP DEVICE. IT IS UNKNOWN IF A DELAY WAS REPORTED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20204168 ↗
• MalfunctionDec 31, 2023Break; Break

  IT WAS REPORTED THAT DURING A IM NAIL PROCEDURE, ONE (1) GRIPPER WAS FOUND BROKEN, NO LONGER FUNCTIONING AS EXPECTED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18423042 ↗
• MalfunctionDec 20, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION A GRIPPER BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY 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 18369755 ↗
• MalfunctionJun 18, 2021Loose or Intermittent Connection; Naturally Worn; Loose or Intermittent Connection; Naturally Worn

  IT WAS REPORTED THAT, DURING TRAUMA PROCEDURE, THE GRIPPER WAS NO LONGER HOLDING THE GUIDE WIRE, DUE TO WEAR AND TEAR. NO SURGICAL DELAY WAS REPORTED. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12029067 ↗
• MalfunctionMay 28, 2021Difficult to Open or Close; Mechanical Jam; Difficult to Open or Close; Mechanical Jam

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE TRIGEN GRIPPER HANDLE USED TO GRIP ONTO THE BALL TIP GUIDE WIRE WAS JAMMED AND WILL NO LONGER OPEN OR CLOSE. 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 11901650 ↗
• MalfunctionMay 28, 2021Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, UPON ATTEMPTING TO GRIP THE WIRE/PIN, THE GRIPPER FAILS TO HOLD ITS GRIP. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11901554 ↗
• MalfunctionMay 26, 2021Connection Problem; Naturally Worn; Connection Problem; Naturally Worn

  IT WAS REPORTED THAT, A TRIGEN GRIPPER DEVICE, DID NOT PERFORMED GRIPPING FUNCTION AND CAN NOT BE ADJUSTED BECAUSE IS WORN. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11885919 ↗
• InjuryMay 14, 2021Break; Fitting Problem; Break; Fitting Problem

  IT WAS REPORTED THAT DURING TRAUMA SURGERY, THE INNER WORKINGS OF THE GRIPPER WAS BROKEN AND BEYOND REPAIR. IT WAS UNABLE TO GRIP ONTO GUIDE ROD. IT WAS USED VICE GRIPS INSTEAD (CHANGE IN SURGICAL TECHNIQUE). NO INJURY O SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11828848 ↗
• MalfunctionMay 13, 2021Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, IT WAS NOTICED THAT THE GRIPPER WAS MALFUNCTIONING AND NO LONGER GRIPPED THE GUIDE ROD. APPEARS TO HAVE BECOME FAULTY AS A RESULT OF HEAVY USE AND WEAR & TEAR. THERE WAS A DELAY OF 30 MINUTES OR LESS AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED. 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 11821439 ↗
• MalfunctionMay 6, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A GRIPPER WAS NOT TIGHTENING EASILY. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY OR NOT, AND IF THERE WAS PATIENT INVOLVEMENT. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11781854 ↗
• MalfunctionMay 5, 2021Break; Break

  IT WAS REPORTED THAT AFTER SURGERY, THE GRIPPER WAS NOT GRIPPING THE GUIDE ROD AS TIGHT AS IT SHOULD, DEFECTIVE SPRING. NO INJURY REPORTED. NO DELAY. AFTER PRODUCT EVALUATION IT WAS DETERMINED THAT THE GRIPPER HAS A BROKEN RELEASE LEVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11776791 ↗
• MalfunctionApr 29, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING SURGERY THE GRIPPER WAS NOT ABLE TO GRIP THE GUIDE RODS. NO SIGNIFICANT DELAY WAS REPORTED AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11743223 ↗
• MalfunctionApr 6, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A TIBIAL NAIL CASE, THE GRIPPER WAS FOUND TO NOT GRASP THE GUIDE ROD AT ALL. THE FAILURE WAS NOTICED DURING USE. THE PROCEDURE WAS COMPLETED USING A SN BACKUP DEVICE. A DELAY OF 30 MINUTES OR LESS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617593 ↗
• MalfunctionFeb 21, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING USE, OUTSIDE THE PATIENT, THE GRIPPER WOULD NOT LONGER LOCK ON TO THE GUIDE ROD DUE TO OVERUSE. 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 11356775 ↗
• MalfunctionFeb 19, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SURGERY, GRIPPER WAS NOT GRIPPING BALL TIP ROD. PROCEDURE CONTINUED WITH THE SAME DEVICE, WITHOUT A DELAY OF LESS THAN 30 MINUTES AND WITHOUT AN INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11347209 ↗
• MalfunctionFeb 15, 2021Break; Break

  IT WAS REPORTED THAT AFTER PROCEDURE, HE EXTENSION STRING HAS BROKEN, RENDERING THE GRIPPER TO BE DEFECTIVE. THE PROCEDURE FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. NO SURGICAL DELAY. PATIENT INJURIES WERE NOT 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 11326716 ↗
• MalfunctionFeb 14, 2021Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT THE GRIPPER HANDLE BROKE. THE SPRING BROKE AND WOULD NOT ALLOW THE HANDLE TO STAY SHUT. THIS WAS DISCOVERED POST SURGERY INSPECTION. THE OUTCOME OF THE SURGERY WAS NOT ALTERED AND A SN BACK UP WAS AVAILABLE IF NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11326120 ↗
• MalfunctionFeb 3, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT, DURING STERILIZATION IT WAS NOTICED THAT THE GUIDEWIRE GRIPPER DOES NOT GRIP. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 11270877 ↗
• MalfunctionJan 24, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING INTERTAN NAILING, THE GRIPPER WAS NOT HOLDING THE WIRE SO THE SURGEON COULD NOT HOLD THE WIRE. PROCEDURE FINISHED WITH S&N BACKUP DEVICE. NO SURGICAL DELAY OR INJURY TO PATIENT REPORTED DUE THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11221239 ↗
• MalfunctionJan 14, 2021Defective Component; Defective Component

  IT WAS REPORTED THAT, DURING SET UP, THE DEVICE COULD NOT PROPERLY GRIP THE GUIDE ROD, ADJUSTING THE KNOB WOULD NOT GET IT TO HOLD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH+NEPHEW BACK UP DEVICE. 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 11169569 ↗
• MalfunctionJan 4, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING FEMUR INTRAMEDULLARY NAILING, AFTER LOADING OF THE WIRE, THE GRIPPER HANDLE WAS FOUND NOT WORKING. NO PATIENT INJURY OR DELAY. BACK-UP S+N DEVICE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11109165 ↗
• MalfunctionDec 28, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT, DURING THE PROCEDURE, AFTER LOADING OF THE WIRE, THE GRIPPER HANDLE WAS FOUND NOT WORKING. THE INCIDENT OCCURRED OUTSIDE THE PATIENT. THE SURGERY WAS COMPLETED WITHOUT DELAY, USING A BACKUP FROM SMITH & NEPHEW. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11084312 ↗
• MalfunctionDec 16, 2020Break; Break

  IT WAS REPORTED THAT THE LOCKING MECHANISM OF THE GRIPPER FELL APART. NO CASE WAS INVOLVED. 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 11016089 ↗
• MalfunctionNov 18, 2020Defective Device; Defective Device

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

  Patient problems: No Patient Involvement

  MAUDE report 10864803 ↗
• MalfunctionNov 11, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE GRIPPER IS NOT GRIPPING THE WIRE CORRECTLY AND IS NOT RELEASING ONCE GRIPPED. EVENT OCCURRED DURING SURGERY, WHILE OUTSIDE THE PATIENT. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10824590 ↗