TRIGEN 71631161Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 03596010478450), received between Jul 16, 2020 and Sep 6, 2024 — classified as 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (6 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. 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.

• MalfunctionSep 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TIBIA INTRAMEDULLARY NAIL PROCEDURE, THE MULTIPURPOSE DRIVER BROKE OUTSIDE THE PATIENT WHEN USING IT TO REMOVE THE TIBIA NAIL. THE DEVICE GOT STUCK IN THE SOFT TISSUE PROTECTOR. SURGERY WAS PERFORMED AFTER A DELAY GREATER THAN 30 MIN, WITH THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20156444 ↗
• MalfunctionMay 28, 2023Crack; Crack

  IT WAS REPORTED THAT, DURING SURGERY, WHILE SURGEON TRIED TO REMOVE SCREW, THE END OF ONE (1) MULTIPURPOSE DRIVER CRACKED RENDERING IT UNABLE TO REMOVE SCREWS. NO PIECES FELL INSIDE OF THE PATIENT. DOCTOR HAD TO USE A MIDAS REX TO BURR THE SCREW HEADS DOWN SINCE THEY WERE CAUSING THE PATIENT PAIN. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, CHANGING THE SURGICAL TECHNIQUE AND WITH A COMPETITOR DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17016088 ↗
• MalfunctionMay 23, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE END OF A MULTIPURPOSE DRIVER BROKE WHILE TRYING TO REMOVE A SCREW FROM AN INTERTAN NAIL THAT WAS CAUSING THE PATIENT PAIN. A MIDAS-REX BURR WAS USED TO CUT SCREWS FROM THE PATIENT'S BONE SO THAT THEY WERE NO LONGER PROTRUDING. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16986740 ↗
• MalfunctionFeb 14, 2022Break; Break

  IT WAS REPORTED THAT THE HEX END OF A MULTIPURPOSE DRIVER IS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13529613 ↗
• InjuryOct 6, 2021Break; Break

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, A MULTIPURPOSE DRIVER BROKE WHILE TRYING TO REMOVE SCREWS FROM TRIGEN NAIL. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT 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 12583032 ↗
• InjurySep 14, 2021Break; Break

  IT WAS REPORTED DURING SURGERY THAT THE TIP OF A MULTIPURPOSE DRIVER BROKE DURING RECON SCREW REMOVAL. PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE, A DELAY OF 30 OR LESS MINUTES WAS REPORTED. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12471634 ↗
• InjurySep 14, 2021Break; Break

  IT WAS REPORTED THAT, DURING TRAUMA SURGERY, THE TIP OF A TRIGEN MULTIPURPOSE DRIVER BROKE OFF WHILE PERFORMING A RECON SCREW REMOVAL. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A COMPETITOR'S BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12471571 ↗
• MalfunctionAug 6, 2021Break; Break

  IT WAS REPORTED THAT THE SHAFT OF A TRIGEN MULTIPURPOSE DRIVER WAS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12291828 ↗
• MalfunctionJun 18, 2021Material Deformation; Mechanical Jam; Material Deformation; Mechanical Jam

  IT WAS REPORTED THAT, DURING A TRAUMA PROCEDURE, THE META-TAN COMP SCREW DRIVER (COVER UNDER (B)(4)) AND THE MULTIPURPOSE DRIVER RETAINING RODS WERE BOTH BENT TOGETHER AT THE TOP ENDS, AND DID NOT ALLOWED THE SCREW DRIVER RELEASE THE HANDLE TO GO INSIDE THEM. NO SURGICAL DELAY WAS REPORTED, AND 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 12022907 ↗
• MalfunctionApr 21, 2021Crack; Crack

  IT WAS REPORTED THAT, DURING A TRAUMA SURGERY, THE DISTAL END OF MULTIPURPOSE DRIVER CRACKED WHILE INSIDE OF THE PATIENT. A SMITH AND NEPHEW BACK UP DEVICE WAS USED. IT IS UNKNOWN IF SURGERY WAS DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11699801 ↗
• MalfunctionMar 28, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SURGERY, THE MULTIPURPOSE DRIVER DID NOT ATTACH TO THE T-HANDLE. THERE WAS NO SURGICAL DELAY AND NO INJURY TO THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11580428 ↗
• MalfunctionMar 15, 2021Break; Break

  IT WAS REPORTED THAT, UPON INSPECTION, THE HEX END OF THE MULTIPURPOSE DRIVER WAS SEEN TO BE BROKEN. NO CASE OR PATIENT 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 11479225 ↗
• InjuryJul 16, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A NAIL REMOTION, THE MULTIPURPOSE DRIVER BROKE WHILE TRYING TO TAKE OUT THE NAIL SCREWS. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK UP DEVICE. SURGERY WAS NOT DELAYED. THE PATIENT WAS NOT HARMED BEYOND THE DESCRIBED EVENT.

  Patient problems: No Information

  MAUDE report 10282977 ↗