TRIGEN 71118226Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 03596010436597), received between Sep 19, 2020 and May 14, 2026 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 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. 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.

• MalfunctionMay 14, 2026Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION, THE 9.0MM FIXED ENDCUTTING RMR BROKE. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE PATIENT. IT IS UNKNOWN HOW PROCEDURE WAS FINISHED AND IF THERE WAS ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25172977 ↗
• MalfunctionJan 27, 2026Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, WHILE MILLING THE MEDULLARY CANAL, ONE (1) 9.0MM FIXED ENDCUTTING RMR BROKE. ALL BROKEN PIECES WERE REMOVED. NO PIECES FELL INTO THE PATIENT'S WOUND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24187333 ↗
• MalfunctionFeb 12, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION, A (1) 9.0MM FIXED ENDCUTTING RMR SNAPPED IN HALF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING 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 21366183 ↗
• MalfunctionDec 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING THE OSTEOSYNTHESIS PROCEDURE, THE NAIL WAS BEING REAMED WITH A SIZE 6 MM TO 9 MM REAMER, WHEN REMOVING THE 9.0MM FIXED ENDCUTTING RMR WITH THE HANDPIECE IN REVERSE, THE REAMER BROKE WITHOUT CAUSING ANY INCONVENIENCE TO THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM. THE PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20920080 ↗
• MalfunctionOct 9, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY (HUMERAL NAIL), THE BALL TIP OF THE GUIDE ROD WAS JAMMED INTO THE END OF ONE (1) 9.0MM FIXED ENDCUTTING RMR, AND AS THEY WERE TRYING TO REMOVE IT, THE ATTACHMENT TO THE DRILL SIDE OF THE REAMER, BROKE IN TWO PIECES. AFTER THE REAMER BROKE, IT WAS ABLE TO REMOVE THE REAMER AND THE BALL TIP FROM THE PATIENT. NO PIECES FELL INTO THE PATIENT. 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 20407661 ↗
• MalfunctionSep 30, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING THE OSTEOSYNTHESIS PROCEDURE, THE 9.0MM FIXED ENDCUTTING RMR BROKE OFF WHEN THE MEDULLARY CANAL WAS FINISHED. THE PIECES FELL INSIDE THE PATIENT. THE DEVICE BROKE IN TWO AND DID NOT REMAIN INSIDE THE CANAL. IT MANAGED TO GET OUT BY RETRACTING THE ENGINE, AND THE PIECE WAS GRABBED WITH ROCHESTER FORCEPS. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. ONCOLOGIC PATIENT, DIAGNOSED WITH BREAST CANCER, DURING THE PROCEDURE WENT INTO CARDIAC ARREST AND AFTER SEVEN ATTEMPTS OF RESUSCITATION DIED IN THE OPERATING ROOM DUE TO NATURAL CAUSES, NOT DUE TO A DEVICE RELATED FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20335262 ↗
• MalfunctionJan 31, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION PROCEDURE, AT THE MOMENT OF REAMING AND REMOVING THE 9.0MM FIXED ENDCUTTING RMR FROM THE PATIENT'S CAVITY, THE DEVICE BROKE IN TWO PARTS. NO PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18613886 ↗
• MalfunctionJan 15, 2024Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE 9.0MM FIXED ENDCUTTING RMR SHAFT BROKE WHILE REAMING HUMERUS. IT IS UNKNOWN IF PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH AN UNKNOWN CHANGE IN SURGICAL TECHNIQUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18513781 ↗
• MalfunctionMay 20, 2022Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT THE 9.0MM FIXED ENDCUTTING RMR WAS DAMAGED. A PICTURE WAS PROVIDED AND IT SEEMS THAT A COMPONENT WAS DETACHED FROM THE MAIN PART AND IT WAS DEFORMED. FURTHER INFORMATION IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 14450723 ↗
• MalfunctionJan 17, 2022Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE OF SHOULDER OSTEOSYNTHESIS, WHILE THE PATIENT'S MEDULLARY CANAL WAS RIMMED, THE OLIVE GUIDE WAS TRAPPED IN THE 9.0MM FIXED ENDCUTTING RMR. WHEN THE OLIVE GUIDE WAS REMOVED, IT WAS EVIDENT THAT THE REAMER WAS BROKEN. NO PIECES FELL INTO THE PATIENT, A SMITH AND NEPHEW BACK UP REAMER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO DAMAGE CAUSED. PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13267265 ↗
• MalfunctionMay 7, 2021Break; Break

  IT WAS REPORTED THAT, DURING USE, A 9.0MM FIXED ENDCUTTING RMR BROKE OUTSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11794728 ↗
• InjuryDec 28, 2020Break; Break

  IT WAS REPORTED THAT DURING AN INSERTION OF HUMERAL TRIGEN LONG NAIL THE 9.0MM FIXED ENDCUTTING RMR BROKE DISTALLY, IT OCCURRED DURING A CENTRIC REAMING ON A GUIDE UPSTREAM OF A HUMERAL NAILING WITH A TRIGEN NAIL. THE PROCEDURE WAS COMPLETED BUT IT WAS DELAYED (NOT SPECIFIED) AND THE INCIDENT GENERATES ADDITIONAL STRESS. A DEBRIS REMAINED IN THE PATIENT BUT THE NAIL WAS IMPLANTED. A STEEL DEBRIS HAS REMAINED IN PLACE, IN CONTACT WITH THE IMPLANT, WHICH COULD GENERATE METALLOSIS. 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 11077710 ↗
• InjurySep 19, 2020Break; Break

  IT WAS REPORTED THAT, WHILE REAMING FOR A HUMERAL NAIL, THE 9.0MM FIXED ENDCUTTING REAMER SHAFT BROKE. ALL PIECES WERE COLLECTED. PROCEDURE CONCLUDED WITH A BACK-UP DEVICE FROM SMITH AND NEPHEW, WITHOUT A DELAY OR AN INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10557824 ↗

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