TRIGEN 71674075Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 03596010560711), received between Nov 16, 2018 and Jul 30, 2024 — classified as 36 malfunctions.

The most frequently reported specific device problem is “Break” (25 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 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2024Break; Break

  IT WAS REPORTED THAT DURING AN INTERTAN PROCEDURE, THE HONEYCOMB BROKE AT THE MOMENT IT WAS INTRODUCED INTO THE KNEE. NO PIECES FELL INTO PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT'S CURRENT HEALTH STATUS IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19862006 ↗
• MalfunctionApr 19, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, A HONEYCOMB WAS USED TO REROUTE THE GUIDE PIN FOR A TIBIA NAIL. IN THE SOFT TISSUE SLEEVE, THE HONEYCOMB BROKE IN HALF INTO TWO PARTS AND HAD TO BE REMOVED WITH A COCHAR. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16771829 ↗
• MalfunctionSep 14, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF A HONEYCOMB WAS FOUND FRACTURED. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15422999 ↗
• MalfunctionJun 11, 2022Break; Break

  IT WAS REPORTED THAT FOLLOWING STERILIZATION, THAT TIP OF THE HONEYCOMB WAS BROKEN AND MISSING NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14671116 ↗
• MalfunctionFeb 2, 2022Crack; Crack

  IT WAS REPORTED THAT DURING SET UP FOR SURGERY, THE END OF THE HONEYCOMB HAS CRACKED OFF. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13429760 ↗
• MalfunctionJan 10, 2022Break; Break

  IT WAS REPORTED THAT THE TIP OF A HONEYCOMB IS BROKEN. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13213923 ↗
• MalfunctionDec 30, 2021Break; Break

  IT WAS REPORTED THAT, DURING THE SET UP FOR AN INTERNAL FIXATION SURGERY, THE PLASTIC END OF A HONEYCOMB WAS NOTICED TO BE BROKEN. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13118973 ↗
• MalfunctionNov 16, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING SET UP FOR SURGERY, THE HONEYCOMB CAME APART. AS THIS HAPPENED BEFORE SURGERY, THERE WAS NO HARM TO PATIENT HOWEVER, THE ISSUE RESULTED ON A CHANGE IN SURGICAL TECHNIQUE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12820190 ↗
• MalfunctionNov 15, 2021Break; Break

  IT WAS REPORTED THAT A 130 RAD DRILL GDE DROP HAS A MISSING PIN ((B)(4)), THE HEX END OF A TRIGEN SHORT HEXDRIVER IS ROUNDED ((B)(4)), THE TIP OF A HONEYCOMB IS BROKEN ((B)(4)), A TRIGEN RULER HAS BROKEN THREADS ((B)(4)), AND A LID FOR OUTER CASES HAS BROKEN CLASP ((B)(4)). AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12817857 ↗
• MalfunctionOct 13, 2021Flaked; Flaked

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, A HONEYCOMB WAS CHIPPED AT THE END. THIS HAPPENED BEFORE USE IN PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12623834 ↗
• MalfunctionOct 1, 2021Flaked; Flaked

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, A HONEYCOMB WAS CHIPPED AT THE END. THIS HAPPENED BEFORE USE IN PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12565444 ↗
• MalfunctionSep 20, 2021Crack; Crack

  IT WAS REPORTED THAT, THE LISTED DEVICES WERE CRACKED OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12496920 ↗
• MalfunctionSep 20, 2021Crack; Crack

  IT WAS REPORTED THAT, THE LISTED DEVICES WERE CRACKED OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12496865 ↗
• MalfunctionSep 20, 2021Crack; Crack

  IT WAS REPORTED THAT, THE LISTED DEVICES WERE CRACKED OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12496862 ↗
• MalfunctionJul 29, 2021Crack; Crack

  IT WAS REPORTED THAT, UPON FIELD INSPECTION, A FLEXIBLE SHAFT W/CIR CONNECTOR ((B)(4)) AND A HONEYCOMB ((B)(4)) WERE FOUND CRACKED. ALSO, A SHORT HEXDRIVER ((B)(4)) AND A REDUCER ((B)(4)) WERE FOUND WITH THEIR THREADS DAMAGED. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12243741 ↗
• MalfunctionJul 14, 2021Break; Break

  IT WAS REPORTED THAT A HONEYCOMB'S TIP BROKE. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT IS UNCERTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12166200 ↗
• MalfunctionJul 13, 2021Break; Break

  IT WAS REPORTED THAT THE TIP OF A TRIGEN HONEYCOMB IS BROKEN OFF. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12158843 ↗
• MalfunctionMar 30, 2021Break; Break

  IT WAS REPORTED THAT DURING AN INSPECTION IN THE WAREHOUSE IT WAS NOTICED THE FAILURE OF DEFECTIVE DEVICES. THE JOURNEY II BCS ARTICULAR INSERT SIZE 1-2 9 MM LEFT ((B)(4)), THE JOURNEY II BCS ARTICULAR INSERT SIZE 1-2 9 MM RIGHT ((B)(4)), TWO UNIVERSAL INSERT SPACER SIZE 1-2 18 MM ((B)(4)), JOURNEY II CR LOCKING FEMORAL IMPACTOR BUMPER RIGHT ((B)(4)), JOURNEY UNI TIBIA INSERT SIZE 1-2/8 MM ((B)(4)), JOURNEY UNI TIBIA TRIAL SIZE 5-6/8 MM ((B)(4)),JOURNEY UNI TIBIA TRIAL SIZE 3-4/8 MM ((B)(4)), THREE HONEYCOMB ((B)(4)), JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 10 MM RIGHT ((B)(4)), THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 10 MM LEFT ((B)(4)) AND THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 12 MM LEFT ((B)(4)) WERE NOTICED CRACKED. TWO COMPRESSION SCREW HEX DRIVER ((B)(4)) AND SCREWDRIVER RELEASE HANDLE ((B)(4)) WERE NOTICED BROKEN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593435 ↗
• MalfunctionMar 30, 2021Break; Break

  IT WAS REPORTED THAT DURING AN INSPECTION IN THE WAREHOUSE IT WAS NOTICED THE FAILURE OF DEFECTIVE DEVICES. THE JOURNEY II BCS ARTICULAR INSERT SIZE 1-2 9 MM LEFT ((B)(4)), THE JOURNEY II BCS ARTICULAR INSERT SIZE 1-2 9 MM RIGHT ((B)(4)), TWO UNIVERSAL INSERT SPACER SIZE 1-2 18 MM ((B)(4)), JOURNEY II CR LOCKING FEMORAL IMPACTOR BUMPER RIGHT ((B)(4)), JOURNEY UNI TIBIA INSERT SIZE 1-2/8 MM ((B)(4)), JOURNEY UNI TIBIA TRIAL SIZE 5-6/8 MM ((B)(4)),JOURNEY UNI TIBIA TRIAL SIZE 3-4/8 MM ((B)(4)), THREE HONEYCOMB ((B)(4)), JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 10 MM RIGHT ((B)(4)), THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 10 MM LEFT ((B)(4)) AND THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 12 MM LEFT ((B)(4)) WERE NOTICED CRACKED. TWO COMPRESSION SCREW HEX DRIVER ((B)(4)) AND SCREWDRIVER RELEASE HANDLE ((B)(4)) WERE NOTICED BROKEN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593413 ↗
• MalfunctionMar 30, 2021Break; Break

  IT WAS REPORTED THAT DURING AN INSPECTION IN THE WAREHOUSE IT WAS NOTICED THE FAILURE OF DEFECTIVE DEVICES. THE JOURNEY II BCS ARTICULAR INSERT SIZE 1-2 9 MM LEFT (B)(4), THE JOURNEY II BCS ARTICULAR INSERT SIZE 1-2 9 MM RIGHT (B)(4), TWO UNIVERSAL INSERT SPACER SIZE 1-2 18 MM (B)(4), JOURNEY II CR LOCKING FEMORAL IMPACTOR BUMPER RIGHT (B)(4), JOURNEY UNI TIBIA INSERT SIZE 1-2/8 MM (B)(4), JOURNEY UNI TIBIA TRIAL SIZE 5-6/8 MM (B)(4), JOURNEY UNI TIBIA TRIAL SIZE 3-4/8 MM (B)(4), THREE HONEYCOMB (B)(4), JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 10 MM RIGHT (B)(4), THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 10 MM LEFT (B)(4) AND THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 12 MM LEFT (B)(4) WERE NOTICED CRACKED. TWO COMPRESSION SCREW HEX DRIVER (B)(4) AND SCREWDRIVER RELEASE HANDLE (B)(4) WERE NOTICED BROKEN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593404 ↗
• MalfunctionMar 30, 2021Break; Break

  IT WAS REPORTED THAT DURING AN INSPECTION IN THE WAREHOUSE IT WAS NOTICED THE FAILURE OF DEFECTIVE DEVICES. IT WAS NOTICED THAT THE NAIL PROX DROP ((B)(4)) HAS A DEFECTIVE ATTACHMENT. FOUR GENESIS II TIBIAL ALIGNMENT SPIKED FIXATION ROD ((B)(4)), THE SCREWDRIVER RELEASE HANDLE ((B)(4)), THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 5-6 9MM RIGHT ((B)(4)), THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 5-6 9MM LEFT ((B)(4)), R3 0 DEG 32 MM TRIAL 48 MM ((B)(4)), THE HONEYCOMB ((B)(4)), THE BOX CHISEL ((B)(4)), JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 11 MM RIGHT ((B)(4)), THE LAG SCREW 3.2 GUIDE PIN SLEEVE ((B)(4)), THE MEDIUM HEXDRIVER ((B)(4)), THE SUBTROC LAG SCREW DRIVER ((B)(4)), THE ACCORD DUAL ENDED HEX DRIVER ((B)(4)) TWO THIN OSTEO BLADE 8X3 ((B)(4)), THE THIN OSTEO BLADE 12X3 ((B)(4)) AND THE JOURNEY DCF AP FEM CUT BLK 4 ((B)(4)) WERE NOTICED CRACKED. THE NAIL PROX DROP ((B)(4)), THE META ANTERIOR DROP ((B)(4)), THE MI Z HANDLE ACET REAMER ((B)(4)) AND TWO THIN OSTEO BLADE 8X3 ((B)(4)) WERE NOTICED BROKEN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593377 ↗
• MalfunctionFeb 11, 2021Break; Break

  IT WAS REPORTED THAT THE HONEYCOMB HAS CRACKED. THE EVENT WAS NOTICED BY THE STERILE STAFF, AFTER SURGERY, NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11312296 ↗
• MalfunctionJan 19, 2021Break; Break

  IT WAS REPORTED THAT A HONEYCOMB WAS FOUND TO BE BROKEN. IT IS UNKNOWN WHEN THIS MALFUNCTION OCCURRED AND IF THERE WAS A DELAY OR A BACK UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11194125 ↗
• MalfunctionJan 8, 2021Break; Break

  IT WAS REPORTED THAT, THE RETAINING CLIP FOR A HONEYCOMB CAME OFF, THE TWO PIECES DO NOT HOLD TOGETHER. INCIDENT OCCURRED DURING TREATMENT WITH INSTRUMENTS OUTSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11141689 ↗
• MalfunctionDec 31, 2020Break; Break

  IT WAS REPORTED THAT, A HONEYCOMB BROKE IN HALF. INCIDENT OCCURRED DURING EFIP INSPECTION FAILURE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11103267 ↗