TRIGEN 71118224Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010436573), received between Feb 11, 2021 and Oct 4, 2023 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING AN HUMERUS OSTEOSYNTHESIS SURGERY AT THE TIME OF RETURNING THE 8.0MM FIXED {} ENDCUTTING RMR, IT BROKE AND REMAINED INSIDE THE PATIENT, HOWEVER IT WAS EXTRACTED AFTER SEVERAL ATTEMPTS. THE PROCEDURE WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY (20MIN) 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 17872327 ↗
• MalfunctionMay 3, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A HUMERUS NAIL SURGERY, THE PROCEDURE BEGAN WITH THE REDUCTION OF THE FRACTURE WITH THE GUIDE AND WAS PERFORMED WITHOUT COMPLICATIONS. WHEN DETERMINING THE DIAMETER OF THE NAIL, THE SURGEON PROCEEDED TO PASS THE DISTAL REAMERS, STARTING WITH THE 6 MM, 7MM, AND WHEN HE PASSED TO THE 8.0MM FIXED ENDCUTTING RMR, WHEN IT REACHED THE DISTAL PART OF THE HUMERUS, THE REAMER SPLIT AND REMAINED INSIDE THE GUIDE. THE TECHNIQUE WAS PERFORMED AS INDICATED, THE SPECIALIST HAS ALREADY WORKED WITH THE S+N PRODUCTS AND KNOWS VERY WELL HOW TO MANIPULATE THEM. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS, WITH A S+N BACK UP DEVICE. THE INCIDENT LASTED ABOUT 5 MINUTES AND THE PATIENT CAME OUT IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16861212 ↗
• MalfunctionApr 25, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A HUMERUS INTERNAL FIXATION PROCEDURE, THE SPECIALIST WAS RHYMING THE MEDULLARY CANAL, AND AT THE TIME OF RETURNING, THE 8.0MM FIXED {} ENDCUTTING RMR BROKE INSIDE OF THE CANAL. THIS WAS SOLVED BY REMOVING THE OLIVE GUIDE WHERE THE BROKEN REAMER CAME OUT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811923 ↗
• MalfunctionJun 10, 2022Break; Break

  IT WAS REPORTED THAT DURING NAIL SURGERY, THE 8.0MM FIXED {} ENDCUTTING RMR BROKE OUTSIDE THE PATIENT. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. NO INJURY TO PATIENT OR DELAY REPORTED. NO PIECES FELL INTO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14655218 ↗
• InjuryJun 9, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, PROCEDURE WAS PERFORMED ACCORDING TO THE TECHNIQUE DESCRIBED, PLACING THE DEFINITIVE IMPLANT 8/7MMX28CM, ONCE THE LAST REAMER WAS REACHED, THERE WAS DIFFICULTY DUE TO THE SPACE OF THE INTRAMEDULLARY CANAL. AT ONE POINT OF THE DRILLING THE RESISTANCE WAS LOST AND, UNDER THE IMAGE INTENSIFIER, IT WAS EVIDENCED THAT THE 8.0MM FIXED ENDCUTTING REAMER BROKE. AN ATTEMPT WAS MADE TO REMOVE THE PIECE USING THE OLIVE GUIDE AND PLIERS, BUT THE OLIVE GUIDE ALSO BROKE. DIFFERENT MANEUVERS WERE PERFORMED TO EXTRACT THE BROKEN PIECES, AND FINALLY, THE REST OF THE GUIDE AND THE REAMER WERE REMOVED. BUT UNDER THE OBSERVATION OF IMAGE INTENSIFIERS IT WAS EVIDENT THAT THERE WAS STILL A PIECE OF THE REAMER IN THE CHANNEL AND THE ANATOMICAL LOCATION IT WAS TOO COMPLEX TO REMOVE. THE PATIENT´S HEALTH CONDITION IS STABLE, AND NO FURTHER COMPLICATIONS WERE REPORTED. THIS SITUATION CAUSED A 2 HOUR DELAY IN THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14640406 ↗
• InjuryApr 6, 2022Break; Break

  IT WAS REPORTED THAT, DURING TRAUMA SURGERY, THE TIP OF THE 8.0MM FIXED ENDCUTTING RMR BROKEN OFF WHILE IN USE. THE PIECE WAS RETRIEVED. 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 14018745 ↗
• InjuryJun 9, 2021Break; Break

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE 8.0MM FIXED ENDCUTTING REAMER BROKE INSIDE THE PATIENT WHILE REAMING THE HUMERUS. 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 11970201 ↗
• MalfunctionMay 13, 2021Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE 8.0MM FIXED ENDCUTTING RMR WAS BROKEN. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. NO PATIENT INJURIES AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11816849 ↗
• MalfunctionFeb 11, 2021Break; Break

  IT WAS REPORTED THAT, THE TIP BROKE OFF A 8.0 MM FIXED ENDCUTTING RMR. 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 11312906 ↗

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