TRIGEN 71118231Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03596010416339), received between Jun 24, 2020 and Feb 9, 2024 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE 9.0MM ENDCUTTING IRH FELL OFF/DETACHED FROM THE FLEXIBLE SHAFT W/CIR CONNECTOR, AND A BALL TIP GUIDE ROD WAS USED TO REMOVE IT. 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 18681621 ↗
• MalfunctionApr 27, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT THE A 9.0MM ENDCUTTING INTERCHANGEABLE REAMER HEAD 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 14226777 ↗
• MalfunctionMar 16, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT A TRIGEN 9.0MM ENDCUTTING INTERCHANGEABLE REAMER HEAD 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 13778114 ↗
• MalfunctionFeb 8, 2022Material Fragmentation; Material Deformation; Material Fragmentation; Material Deformation

  IT WAS REPORTED THAT A 9.0MM ENDCUTTING INTERCHANGEABLE REAMER HEAD WAS 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 13483720 ↗
• MalfunctionNov 19, 2021Break; Dull, Blunt; Break; Dull, Blunt

  IT WAS REPORTED THAT, THE FLEXIBLE SHAFT W/CIR CONNECTOR WAS SEEN TO BE CRACKED AND THE 9.0 MM END CUTTING IRH 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 12844153 ↗
• InjuryApr 12, 2021Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING PROCEDURE OF A META TAN THE 9.0MM ENDCUTTING IRH IS DULL AND WOULD NOT WORK FOR THE CASE. THE PROCEDURE WAS FINISHED USING A COMPETITOR DEVICE. A SYNTHES REAMER WAS USED. NO DELAY OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11648447 ↗
• MalfunctionApr 11, 2021Flaked; Flaked

  IT WAS REPORTED THAT, THERE IS METAL COMING OFF THE SIDES OF ALL 9.0MM ENDCUTTING IRH REAMER HEADS. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646935 ↗
• InjuryOct 19, 2020Break; Break

  IT WAS REPORTED THAT THE EDGE OF THE BLADES BROKE AFTER THE REAMER HIT THE K-WIRE. THE SURGEON USED A 2.4 MM K-WIRE TO BLOCK DURING REAMING. NO DELAY REPORTED. NO PATIENT INJURIES REPORTED. AN S&N BACKUP WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10702636 ↗
• MalfunctionSep 10, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT THERE ARE NO NUMERICAL MARKINGS VISIBLE ON THE FLEX REAMER ENDS AND NURSING OFTEN MIX UP THE REAMER ENDS WHEN THEY ARE BEING ASKED FOR BY THE SURGEON. EVENT OCCURRED DURING SURGERY, WITH INSTRUMENTS OUTSIDE THE PATIENT. PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. A SURGICAL DELAY OF 30 MIN OR LESS WAS REPORTED. NO HARM TO PATIENT WAS REPORTED DUE TO THIS FAILURE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10517807 ↗
• MalfunctionJun 24, 2020Break; Break

  IT WAS REPORTED THAT UPON INSPECTION THE REAMER WAS FOUND CHIPPED AND NEEDED TO BE REPLACED. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10188408 ↗

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