TRIGEN 71631116Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 03596010419583), received between Aug 1, 2020 and Mar 16, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026Fracture

  IT WAS REPORTED THAT, DURING AN INTRAMEDULLARY NAILING SURGERY, ONE (1) 12.5MM ENTRY REAMER FRACTURED. NO PIECES FELL INTO THE PATIENT, AS BOTH PARTS OF THE REAMER REMAINED JOINED. THE PROCEDURE HAD BEEN COMPLETED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24606449 ↗
• MalfunctionJan 8, 2026Material Deformation

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE 12.5MM ENTRY REAMER WAS DULL AND WOULDN'T CUT, THE RULER HAD A BROKEN INTERNAL PLASTIC RING WHICH CAUSED IT TO GIVE A FIXED READING, THE SHAFT OF A MEDIUM HEXDRIVER WOULDN'T FIT INTO THE SLEEVE, IT GOT STUCK, AND WOULDN'T ROTATE TO LOCK THE SCREW TO THE SLEEVE, AND IT WAS SO TIGHT THAT IT PREVENTED THE SCREWDRIVER SHAFT FROM BEING EASILY INSERTED OR REMOVED. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, USING THE SAME DEVICES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24003153 ↗
• MalfunctionJun 30, 2025Break; Break

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, ONE (1) 12.5MM ENTRY REAMER AND ONE (1) FLEXIBLE SHAFT W/CIR CONNECTOR BROKE DURING USE. NO PIECES FELL INSIDE THE WOUND. 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 22353200 ↗
• MalfunctionMay 8, 2023Break; Break

  IT WAS REPORTED THAT, DURING STERILIZATION AFTER AN INTERNAL FIXATION SURGERY, IT WAS NOTICED THAT THE FLEXIBLE SHAFT OF (1) 12.5MM ENTRY REAMER HAD SNAPPED AT THE BASE, RIGHT BEFORE THE BLADE. THE PROCEDURE HAD BEEN COMPLETED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16886673 ↗
• MalfunctionNov 14, 2022Break; Break

  IT WAS REPORTED THAT DURING SURGERY, ONE 12.5MM ENTRY REAMER BROKE WHILE REAMING. 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 15787135 ↗
• MalfunctionOct 5, 2022Fracture; Fracture

  IT WAS REPORTED THAT ONE (1) 12.5MM ENTRY REAMER SEGMENT HAS BROKEN. IT IS UNKNOWN THE PROCEDURE BEING PERFORMANCE, WHEN OCCURRED, IF THERE WAS A DELAY AND HOW WAS THE PROCEDURE FINISHED. PATIENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 15544555 ↗
• MalfunctionOct 4, 2022Material Fragmentation; Material Deformation; Material Fragmentation; Material Deformation

  IT WAS REPORTED THAT, DURING INSPECTION, IT WAS NOTICED THAT A 12.5MM ENTRY REAMER WAS DULL AND CHIPPED. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15537856 ↗
• MalfunctionSep 30, 2022Fracture; Failure to Clean Adequately; Fracture; Failure to Clean Adequately

  IT WAS REPORTED THAT, DURING DECONTAMINATION, A 12.5MM ENTRY REAMER WAS THREW AWAY DURING SPD TECH AND SNAPPED INTO THE MIDDLE OF THE SHAFT. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. AS THIS WAS NOTICED IN A NON SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15514995 ↗
• MalfunctionAug 17, 2022Fracture; Fracture

  IT WAS REPORTED THAT, THE TIP OF A 12.5MM ENTRY REAMER WAS CHIPPED. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15241067 ↗
• MalfunctionJul 10, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT A 12.5MM ENTRY REAMER IS CHIPPED AND DULL. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14973842 ↗
• MalfunctionMay 25, 2022Break; Break

  IT WAS REPORTED THAT A 12.5MM ENTRY REAMER WAS FOUND DULL/CHIPPED. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14501195 ↗
• MalfunctionMar 4, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT 12.5MM ENTRY REAMER WAS SEEN TO BE CHIPPED AND DULL. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13667838 ↗
• MalfunctionFeb 14, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT A 12.5MM ENTRY REAMER IS DULL AND CHIPPED. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13529589 ↗
• MalfunctionFeb 2, 2022Break; Dull, Blunt; Break; Dull, Blunt

  IT WAS REPORTED THAT A TRIGEN 12.5MM ENTRY REAMER IS CHIPPED AND DULL. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13429427 ↗
• MalfunctionNov 22, 2021Break; Dull, Blunt; Break; Dull, Blunt

  IT WAS REPORTED THAT A 12.5 MM ENTRY REAMER IS CHIPPED AND DULL. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT. 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 12852854 ↗
• MalfunctionNov 15, 2021Break; Dull, Blunt; Break; Dull, Blunt

  IT WAS REPORTED THAT A MEDIUM HEXDRIVER AND A LONG HEXDRIVER HAVE DAMAGE THREADS, A 12.5MM ENTRY REAMER IS CHIPPED AND DULL, A LID FOR OUTER CASES HAS A BROKEN CLASP AND A RULER HAS BROKEN THREADS. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12817118 ↗
• MalfunctionAug 16, 2021Break; Dull, Blunt; Break; Dull, Blunt

  IT WAS REPORTED THAT A RULER HAS BROKEN THREADS, A T-HANDLE HAS BROKEN TABS, A 12.5MM ENTRY REAMER IS DULL AND CHIPPED, A SHORT HEXDRIVER HAS DAMAGED THREADS AND A SCREW LENGTH SLEEVE IS CRACKED AT THE JOINT. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12326700 ↗
• MalfunctionJul 30, 2021Flaked; Dull, Blunt; Flaked; Dull, Blunt

  IT WAS REPORTED THAT A TRIGEN RULER'S (B)(4) THREADS WERE BROKEN, A TRIGEN 12.5 MM ENTRY REAMER (B)(4) WAS DULL AND CHIPPED, A TRIGEN LAG SCREW DRIVER (B)(4) HAD A DAMAGED CONNECTION END, AND A TRIGEN REDUCER (B)(4) HAD A MISSING DISTAL PIECE. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12250809 ↗
• MalfunctionJun 28, 2021Crack; Crack

  IT WAS REPORTED THAT, DURING SET UP OR INSPECTION, A 12.5MM ENTRY REAMER CRACKED. THE PROCEDURE WAS COMPLETED USING A S+N BACK-UP DEVICE. SURGERY WAS LESS THAN OR EQUAL TO 30MINS DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12077091 ↗
• MalfunctionJun 22, 2021Break; Dull, Blunt; Break; Dull, Blunt

  IT WAS REPORTED THAT A 12.5MM ENTRY REAMER WAS CHIPPED AND DULL. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12042945 ↗
• MalfunctionMay 11, 2021Break; Dull, Blunt; Break; Dull, Blunt

  IT WAS REPORTED THAT DURING SERVICE/PM THE 12.5MM ENTRY REAMER WAS CHIPPED AND DULLED. AS THIS HAPPENED DURING SERVICE AND REPAIR ACTIVITIES, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11807575 ↗
• MalfunctionMay 11, 2021Material Fragmentation; Dull, Blunt; Material Fragmentation; Dull, Blunt

  IT WAS REPORTED THAT, DURING SERVICE, A 12.5MM ENTRY REAMER WAS FOUND TO BE CHIPPED AND DULLED. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11807478 ↗
• MalfunctionMar 15, 2021Fracture; Dull, Blunt; Fracture; Dull, Blunt

  IT WAS REPORTED THAT, UPON INSPECTION, THE 12.5MM ENTRY REAMER WAS SEEN TO BE DULL/CHIPPED. 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 11479226 ↗
• MalfunctionFeb 12, 2021Break; Dull, Blunt; Break; Dull, Blunt

  IT WAS REPORTED THAT, DURING EFIP INSPECTION WAS NOTICED THAT, 12.5MM ENTRY REAMER EDGES ARE DULL AND CHIPPED. INCIDENT OCCURRED BEFORE THE PROCEDURE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11320025 ↗
• MalfunctionJan 14, 2021Break; Break

  IT WAS REPORTED THAT THE 12.5MM ENTRY REAMER WAS FOUND DEFECTIVE. NO CASE INVOLVED. RESULTS OF INVESTIGATION CONFIRMED THAT THE TIP OF THE DEVICE IS FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11174492 ↗

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