TRIGEN 71674076Recalls & reported problems

Summary

The FDA's MAUDE database contains 111 adverse event reports that list this exact device (DI 03596010560728), received between Jan 18, 2018 and Jun 15, 2026 — classified as 11 injuries, 100 malfunctions.

The most frequently reported specific device problem is “Break” (83 reports).

2 other recalls cover devices cleared under the same FDA submission (K123598); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 111 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING A INTERNAL FIXATION SURGERY, ONE (1) T-HANDLE WAS MISSING. THEREFORE, THE PROXIMAL PLUG COULD NOT BE PLACED. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30MIN, USING A COMPETITOR DEVICE. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25498106 ↗
• MalfunctionMay 27, 2026Fracture

  IT WAS REPORTED THAT, DURING AN INTERTAN FEMORAL NAIL SURGERY, ONE (1) T-HANDLE HAD A LIP NEAR THE CONNECTION POINT THAT BROKE OFF DURING SCREW INSERTION. NO PIECES WERE INSIDE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25310918 ↗
• MalfunctionAug 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, ONE (1) T-HANDLE WAS BROKEN, THE CAPTURE LATCH OF THE ATTACHMENT MECHANISM SHEARED OFF, ONE SIDE THEN THE OTHER. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A COMPETITOR SYNTHES T-CHUCK HANDLE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22912704 ↗
• MalfunctionJun 21, 2025Break; Break

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION, PART OF ONE (1) T-HANDLE BROKE, LEAVING JAGGED EDGE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22303879 ↗
• MalfunctionJun 20, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE LEVER OF THE T-HANDLE GETS STUCK AND IT ALSO BROKE. IT IS UNKNOWN HOW THE SURGERY WAS COMPLETED OR IF THIS CAUSED A SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19574871 ↗
• MalfunctionJun 6, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY IN ONE (1) T-HANDLE THE CONNECTION POINT TO HEX DRIVER BROKE OFF. NO PIECES FELL INSIDE THE PATIENT. 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 17071842 ↗
• MalfunctionApr 19, 2022Break; Break

  IT WAS REPORTED THAT, DURING THE SET UP FOR AN INTERNAL FIXATION SURGERY, THE ATTACHMENT END OF A T-HANDLE SHEARED. SURGERY WAS PERFORMED, 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 14140709 ↗
• MalfunctionApr 1, 2022Break; Break

  IT WAS REPORTED THAT, A T-HANDLE HAS BROKEN TABS. AS THIS WAS NOTICE IN A FIELD INSPECTION, NOT PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13982757 ↗
• MalfunctionMar 31, 2022Break; Break

  IT WAS REPORTED THAT A T-HANDLE HAVE BROKEN TABS. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13961669 ↗
• MalfunctionMar 28, 2022Break; Mechanics Altered; Break; Mechanics Altered

  IT WAS REPORTED THAT, DURING SURGERY, THE T-HANDLE BROKE AND DID NOT ATTACH PROPERLY. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT SIGNIFICANT DELAYS. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13927515 ↗
• InjuryMar 24, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE T-HANDLE BROKE INSIDE PATIENT. ALL PIECES WERE RETRIEVED FROM THE PATIENT. IT IS UNKNOWN HOW THE PIECES WERE RETRIEVED. SURGERY WAS RESUMED, WITHOUT ANY DELAY, USING A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED BEYOND THE ISSUE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13896551 ↗
• MalfunctionMar 8, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT TWO T-HANDLE WAS FOUND BREAKING AND STRIPPING. IT IS UNKNOWN WHEN THIS WAS NOTICED AND IF THERE WAS A PATIENT INVOLVED.

  Patient problems: Insufficient Information

  MAUDE report 13698357 ↗
• MalfunctionFeb 23, 2022Break; Break

  IT WAS REPORTED THAT, A T-HANDLE HAS BROKEN TABS. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13583477 ↗
• MalfunctionFeb 10, 2022Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT, DURING A INTERNAL FIXATION SURGERY, THE CHUCKING MECHANISM FLANGE OF A TRIGEN T-HANDLE BROKE DURING LOCK OF NAIL TO GUIDE WITH PUMPKIN HEAD SCREWDRIVER. FRACTURE OF METAL APPEARED TO BE FROM WEAR AND FATIGUE. IT IS UNKNOWN IF ANY PIECES FELL INSIDE OF THE PATIENT. ALSO IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO DELAY WAS REPORTED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13509562 ↗
• MalfunctionFeb 8, 2022Crack; Crack

  IT WAS REPORTED THAT A T-HANDLE HAS CRACKED TABS. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13483525 ↗
• MalfunctionFeb 7, 2022Break; Break

  IT WAS REPORTED THAT A T-HANDLE HAS BROKEN TABS. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13470326 ↗
• MalfunctionFeb 1, 2022Crack; Crack

  IT WAS REPORTED THAT A T-HANDLE HAS CRACKED TABS. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13416161 ↗
• MalfunctionJan 31, 2022Break; Break

  IT WAS REPORTED THAT A T-HANDLE BROKE. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13403565 ↗
• MalfunctionJan 28, 2022Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE T-HANDLE BROKE WHILE THE SURGEON WAS IMPLANTING A 5.0MM TRIGEN SCREW. NO PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT SIGNIFICANT DELAYS. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13389498 ↗
• MalfunctionJan 26, 2022Break; Break

  IT WAS REPORTED THAT A T-HANDLE BROKE DURING TRANSIT. AS THIS WAS NOTICED DURING AN INSPECTION, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13353566 ↗
• MalfunctionDec 9, 2021Break; Break

  IT WAS REPORTED THAT A TRIGEN T-HANDLE BROKE. THE CONTEXT IN WHICH THIS OBSERVATION WAS MADE IS UNSPECIFIED. THEREFORE, PATIENT INVOLVEMENT IS YET TO BE CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12966925 ↗
• MalfunctionNov 30, 2021Break; Break

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE T-HANDLE BROKE. INCIDENT OCCURRED OUTSIDE PATIENT, AND NO PIECES FELL INSIDE. THERE WAS NO DELAY AND THE PROCEDURE WAS FINISHED WITH A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12894276 ↗
• MalfunctionNov 23, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE SCRUB TECH WAS TRYING TO CONNECT T-HANDLE TO THE SET SCREW DRIVER AND A PLASTIC PIECE BROKE OFF; NOT ALLOWING THE T-HANDLE TO ATTACH. 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 12863693 ↗
• MalfunctionNov 22, 2021Break; Break

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, THE TIP OF A TRIGEN T-HANDLE BROKE OUTSIDE THE PATIENT. NO PIECES FELL INTO THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12857810 ↗
• MalfunctionNov 15, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE TIP OF A T-HANDLE WAS BROKEN AND THE ENTRY PORTAL HANDLE DID NOT WORK. SURGERY WAS RESUMED, WITHOUT A LESS THAN OR EQUAL TO 30 MINUTES, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12817314 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123598. One submission often covers many models, so check the product and lot details in each record.

• Z-0730-2019 · Jan 7, 2019 · Terminated
  SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
• Z-1008-2017 · Nov 16, 2016 · Terminated
  REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116