TRIGEN 71118228Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010436610), received between Jan 14, 2021 and Nov 14, 2024 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN ORIF SURGERY, ONE (1) 10MM FIXED ENDCUTTING RMR FRACTURED WITHIN THE MEDULLARY CANAL. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY USING THE SAME DEVICE, AND NO INJURIES WERE REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20683800 ↗
• MalfunctionApr 11, 2023Fracture; Fracture

  IT WAS REPORTED THAT, WHILE REAMING THE MEDULLARY CANAL IN AN INTRAMEDULLARY NAIL PROCEDURE, THE 10MM FIXED ENDCUTTING RMR BROKE INSIDE THE MEDULLARY CANAL. PLIERS WERE REQUESTED AND WITH THE HELP OF THE IMPACTOR WAS REMOVED FROM THE MEDULLARY CANAL. THIS CAUSED A 40 MINUTE DELAY IN THE PROCEDURE. THEN A OLIVE GUIDE WAS REQUESTED TO INTRODUCE THE NAIL INTO THE BONE. WHEN THE GUIDE WAS GOING TO BE REMOVED, IT DID NOT PASS THROUGH THE NAIL BECAUSE THE GUIDE WAS TOO THICK. THE SURGEON HAD TO RETRIEVED THE NAIL WITH THE GUIDE AND THEN HE INSERTED THE NAIL INTO THE BONE WITHOUT THE GUIDE. ADDITIONALLY, THE ARC OF NAIL INSERTION WAS DESCALIBRATED, THEREFORE, THE DRILL BITS DIDN'T COINCIDE EXACTLY WITH THE HOLES IN THE NAIL. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16717338 ↗
• MalfunctionJun 7, 2022Break; Break

  IT WAS REPORTED THAT ONE 10MM FIXED ENDCUTTING RMR BROKE. FURTHER INFORMATION IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14611697 ↗
• MalfunctionSep 29, 2021Break; Break

  IT WAS REPORTED THAT, A 10MM FIXED ENDCUTTING RMR IS BROKEN, THE EDGE OF A SMALL OUTER CASE - 2.4 IS BROKEN AND THE LID FOR OUTER CASES HAS THE HANDLE BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12546379 ↗
• InjurySep 10, 2021Fracture; Mechanical Jam; Fracture; Mechanical Jam

  IT WAS REPORTED THAT DURING A HUMERO INTRAMEDULLARY NAIL PROCEDURE, THE MOTOR OF A 10.0MM SCULPTOR FIXED ENDCUTTING REAMER STOPPED AND REAMER DID NOT ADVANCE, REAMER WAS REMOVED AND IT WAS EVIDENCED THAT ITS DISTAL PART WAS FRACTURED, THE BROKEN PIECE WAS REMOVED WITH TWEEZERS. 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 12453213 ↗
• MalfunctionJan 14, 2021Break; Break

  IT WAS REPORTED THAT THE 10MM FIXED ENDCUTTING REAMER BROKE WHEN CLEANED BY CSSD. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11169200 ↗

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