TRIGEN 71129402Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010415103), received between Apr 11, 2021 and Apr 11, 2021 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Component Missing” (7 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT DURING A FIELD INSPECTION THE IPG MIS DCF AP CT BLK 3 WAS NOTED TO BE RUSTY AND DISCOLORED, THE EXTRAMEDULAR ALIGNMENT ROD WAS BROKEN, THE GII QUICK CONNECT HANDLE DENTED AND DID NOT RETRACT, THE IPG PS HIGH FLEX IMPCTR HD 1-2 GII PS HIGH FLEX IMPCTR HD 3-8, GII TIBIAL BASE IMPACTOR, GII NARROW PCL RETRACTOR, 11MM GNS II TIBIAL DRILL WITH BURRS AND GOUGES AND OUTER HOUSING CAP WITH ONE COMPONENT MISSING AND BROKE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT PARTICIPATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646830 ↗
• InjuryApr 11, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT DURING A FIELD INSPECTION THE IPG MIS DCF AP CT BLK 3 WAS NOTED TO BE RUSTY AND DISCOLORED, THE EXTRAMEDULAR ALIGNMENT ROD WAS BROKEN, THE GII QUICK CONNECT HANDLE DENTED AND DID NOT RETRACT, THE IPG PS HIGH FLEX IMPCTR HD 1-2 GII PS HIGH FLEX IMPCTR HD 3-8, GII TIBIAL BASE IMPACTOR, GII NARROW PCL RETRACTOR, 11 MM GNS II TIBIAL DRILL WITH BURRS AND GOUGES AND OUTER HOUSING CAP WITH ONE COMPONENT MISSING AND BROKE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT PARTICIPATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646829 ↗
• MalfunctionApr 11, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT DURING A FIELD INSPECTION THE IPG MIS DCF AP CT BLK 3 WAS NOTED TO BE RUSTY AND DISCOLORED, THE EXTRAMEDULAR ALIGNMENT ROD WAS BROKEN, THE GII QUICK CONNECT HANDLE DENTED AND DID NOT RETRACT, THE IPG PS HIGH FLEX IMPCTR HD 1-2 GII PS HIGH FLEX IMPCTR HD 3-8, GII TIBIAL BASE IMPACTOR, GII NARROW PCL RETRACTOR, 11MM GNS II TIBIAL DRILL WITH BURRS AND GOUGES AND OUTER HOUSING CAP WITH ONE COMPONENT MISSING AND BROKE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT PARTICIPATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646828 ↗
• MalfunctionApr 11, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT DURING A FIELD INSPECTION THE IPG MIS DCF AP CT BLK 3 WAS NOTED TO BE RUSTY AND DISCOLORED, THE EXTRAMEDULARY ALIGNMENT ROD WAS BROKEN, THE GII QUICK CONNECT HANDLE DENTED AND DID NOT RETRACT, THE IPG PS HIGH FLEX IMPCTR HD 1-2 GII PS HIGH FLEX IMPCTR HD 3-8, GII TIBIAL BASE IMPACTOR, GII NARROW PCL RETRACTOR, 11MM GNS II TIBIAL DRILL WITH BURRS AND GOUGES AND OUTER HOUSING CAP WITH ONE COMPONENT MISSING AND BROKE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT PARTICIPATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646826 ↗
• MalfunctionApr 11, 2021Break; Component Missing; Break; Component Missing

  IT WAS REPORTED THAT DURING A FIELD INSPECTION THE IPG MIS DCF AP CT BLK 3 WAS NOTED TO BE RUSTY AND DISCOLORED, THE EXTRAMEDULAR ALIGNMENT ROD WAS BROKEN, THE GII QUICK CONNECT HANDLE DENTED AND DID NOT RETRACT, THE IPG PS HIGH FLEX IMPCTR HD 1-2 GII PS HIGH FLEX IMPCTR HD 3-8, GII TIBIAL BASE IMPACTOR, GII NARROW PCL RETRACTOR, 11 MM GNS II TIBIAL DRILL WITH BURRS AND GOUGES AND OUTER HOUSING CAP WITH ONE COMPONENT MISSING AND BROKE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT PARTICIPATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646825 ↗
• MalfunctionApr 11, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT DURING A FIELD INSPECTION THE IPG MIS DCF AP CT BLK 3 WAS NOTED TO BE RUSTY AND DISCOLORED, THE EXTRAMEDULAR ALIGNMENT ROD WAS BROKEN, THE GII QUICK CONNECT HANDLE DENTED AND DID NOT RETRACT, THE IPG PS HIGH FLEX IMPCTR HD 1-2 GII PS HIGH FLEX IMPCTR HD 3-8, GII TIBIAL BASE IMPACTOR, GII NARROW PCL RETRACTOR, 11MM GNS II TIBIAL DRILL WITH BURRS AND GOUGES AND OUTER HOUSING CAP WITH ONE COMPONENT MISSING AND BROKE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT PARTICIPATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646823 ↗
• MalfunctionApr 11, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT DURING A FIELD INSPECTION THE IPG MIS DCF AP CT BLK 3 WAS NOTED TO BE RUSTY AND DISCOLORED, THE EXTRAMEDULAR ALIGNMENT ROD WAS BROKEN, THE GII QUICK CONNECT HANDLE DENTED AND DID NOT RETRACT, THE IPG PS HIGH FLEX IMPCTR HD 1-2 GII PS HIGH FLEX IMPCTR HD 3-8, GII TIBIAL BASE IMPACTOR, GII NARROW PCL RETRACTOR, 11MM GNS II TIBIAL DRILL WITH BURRS AND GOUGES AND OUTER HOUSING CAP WITH ONE COMPONENT MISSING AND BROKE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT PARTICIPATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646822 ↗