TRIGEN 71654501Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 03596010585820), received between Sep 7, 2018 and Apr 28, 2026 — classified as 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “Break” (11 reports).

1 other recall cover devices cleared under the same FDA submission (K122170); 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Failure to Align

  IT WAS REPORTED THAT, DURING A TIBIAL NAIL SURGERY, THE SURGEON TESTED EVERY SCREW TRAJECTORY IN ONE (1) META ANTERIOR DROP WITH THE 4.0 LONG DRILL AND THE 9.0/4.0 DRILL SLEEVE, ALL BUT ONE SCREW HOLE PASSED THE DRILL WITH EASE. UPON THE A PROXIMAL HOLE, THE 4.0 LONG DRILL WOULD SLIGHTLY CATCH ON THE NAIL, UPON INSERTION OF THE SCREW IN THAT PROXIMAL HOLE, THE SCREW COMPLETELY MISSED THE NAIL. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25024075 ↗
• MalfunctionFeb 1, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, ONE (1) TRIGEN META ANTERIOR DROP DID NOT FIT WELL INTO A TRIGEN STANDARD DRILL GUIDE, TO WHICH THE NAILED WAS ANCHORED AND THE GRAFT OF THE BOW DID NOT ALLOW EASY INSERTION. IN FACT, TO REMOVE IT, THE TRIGEN META ANTERIOR DROP SPLIT. IT IS UNKNOWN IF PIECES FELL INTO THE PATIENT. IT IS UNKNOWN HOW SURGERY WAS COMPLETED AN IF THERE WAS A DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16277955 ↗
• MalfunctionApr 9, 2022Break; Break

  IT WAS REPORTED THAT, DURING TRAUMA SURGERY, A TRIGEN META ANTERIOR DROP BROKE OUTSIDE THE PATIENT. NO PIECES FELL INTO PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14068630 ↗
• MalfunctionMar 16, 2022Break; Break

  IT WAS REPORTED THAT DURING A SURGERY, AFTER INSERTING A TIBIAL NAIL, THE SURGEON ATTEMPTED TO ADJUST THE NAIL POSITION, AND WHILE DOING IT, THE META ANTERIOR DROP CAUGHT ON THE CLAMPS HOLDING THE FRACTURE REDUCTION AND BROKE. NO PIECES FELL INTO PATIENT. THEN, THE BACK UP ANTERIOR DROP WOULD NOT ATTACH TO THE SEMIEXTENDED GUIDE BOLT, AS A CONNECTION PRONG HAD BEEN BENT WHEN THE META ANTERIOR DROP BROKE. PERFECT CIRCLE TECHNIQUE WAS USED TO IMPLANT SCREWS PROXIMALLY. 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 13776997 ↗
• MalfunctionJan 10, 2022Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE META ANTERIOR DROP BROKE. NO PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAY. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13214279 ↗
• MalfunctionDec 9, 2021Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING SET UP FOR SURGERY, A META ANTERIOR DROP WAS CHIPPED, CONTINUALLY HAS ONE OF THE INTERNAL SCREWS MIGRATING UP AND IN THE WAY OF THE TIBIAL LOCKING SCREW TARGETING HOLE. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. SINCE INCIDENT OCCURRED BEFORE PROCEDURE, PATIENT WAS NOT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12966904 ↗
• MalfunctionNov 17, 2021Flaked; Flaked

  IT WAS REPORTED THAT A TRIGEN OBTURATOR ((B)(4)) IS DAMAGED, THE CAPTURING ROD FELL OUT OF THE TRIGEN LAG SCREW DRIVER ((B)(4)) AND CRACKED ON IMPACT WITH THE FLOOR, AND A PIECE OF THE CARBON FIBER OF A TRIGEN META ANTERIOR DROP ((B)(4)) WAS CHIPPED OFF DUE TO FORCE. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12831946 ↗
• MalfunctionOct 27, 2021Break; Break

  IT WAS REPORTED THAT, WHEN THE STERILE PACK WAS OPENED, A TRIGEN META ANTERIOR DROP WAS OBSERVED TO BE BROKEN. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12705508 ↗
• MalfunctionAug 10, 2021Contamination; Contamination

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION PROCEDURE, SOMETHING THAT SEEMED TO BE LIKE ¿BURNT¿ PLASTIC CAME OUT OF ONE OF THE DRILL HOLES OF A META ANTERIOR DROP WHEN THE DRILL AND SCREW SLEEVES WERE INSERTED. THE PROCEDURE WAS FINISHED WITHOUT DELAY USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12304591 ↗
• MalfunctionJun 22, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT IT WAS DIFFICULT FOR THE SURGEON TO LOCK ON A META-NAIL ANTERIOR DROP ON JUNE 7TH DURING INTERNAL FIXATION SURGERY. NO INJURY REPORTED. IT IS UNKNOWN WHETHER THERE WAS A SURGICAL DELAY AND HOW THE SURGERY WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12042876 ↗
• MalfunctionJun 22, 2021Crack; Crack

  IT WAS REPORTED THAT, THE BOTTOM OF A META-NAIL ANTERIOR DROP IS CRACKED. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12042870 ↗
• MalfunctionMay 24, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, A META ANTERIOR DROP IS HARD TO MANTLE AND DISMANTLE. AS THIS WAS NOTICED DURING INSPECTION ACTIVITIES, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11872867 ↗
• MalfunctionApr 22, 2021Failure to Align; Material Deformation; Failure to Align; Material Deformation

  IT WAS REPORTED THAT DURING KNEE SURGERY TWO META ANTERIOR DROPS WERE DEFORMED AND NOT TARGETING THE NAIL ADEQUATELY. THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE. A DELAY OF LESS THAN OR EQUAL TO 30MINS WAS REPORTED. NO INJURY REPORTED. 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 11711038 ↗
• MalfunctionApr 22, 2021Failure to Align; Material Deformation; Failure to Align; Material Deformation

  IT WAS REPORTED THAT DURING KNEE SURGERY TWO META ANTERIOR DROPS WERE DEFORMED AND NOT TARGETING THE NAIL ADEQUATELY. THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE. A DELAY OF LESS THAN OR EQUAL TO 30MINS WAS REPORTED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11711037 ↗
• MalfunctionApr 18, 2021Connection Problem; Naturally Worn; Connection Problem; Naturally Worn

  IT WAS REPORTED THAT, A META ANTERIOR DROP ((B)(4)) AND A SEMIEXTENDED DRILL GUIDE (SEMIEXTENDED DRILL GUIDE) WILL NOT LOCK IN PLACE, BOTH ITEMS ARE WORN. A BACKUP DEVICE WAS AVAILABLE, THERE WAS NO DELAY OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683486 ↗
• MalfunctionApr 6, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT, DURING SET UP OR INSPECTION, THE META ANTERIOR DROP DOESN'T ENGAGE WITH THE INSERTER. THERE WAS NO DELAY AND PROCEDURE WAS PERFORMED WITH A BACKUP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11624906 ↗
• 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 11593366 ↗
• MalfunctionAug 13, 2020Break; Break

  IT WAS REPORTED THAT AFTER THE PROCEDURE, IT WAS FOUND THAT THE UNDERSIDE OF DROP WAS CHIPPED WHERE BLOCKING SCREW ATTACHMENT GOES IN. THERE ARE NOT PATIENT AFFECTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10405294 ↗
• MalfunctionAug 6, 2020Break; Break

  IT WAS REPORTED THAT BEFORE SURGERY, UPON INSPECTION THE META ANTERIOR DROP WAS FOUND CHIPPED. A S&N BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. IT WAS NOT CONFIRMED IF THERE WAS A DELAY. NO INJURIES REPORTED AT THIS TIME FOR THIS CASE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10376038 ↗
• InjuryJun 24, 2020Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING SURGERY, THE SURGEON COULD NOT ATTACH THE META-NAIL ANTERIOR DROP TO THE DRILL GUIDE WITHOUT USING THE MALLET TO GENTLY TAP IT ON. THIS HELD UP THE CASE FOR A FEW MINUTES. PROCEDURE WAS COMPLETED USING THE SAME DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10188026 ↗
• MalfunctionMay 21, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY, DEVICE BROKE DURING IMPACTION. NOTHING GOT INTO THE PATIENT. NO HARM TO PATIENT OR STAFF. 2 MINUTES DELAY IN PROCEDURE DUE TO INCIDENT. SMITH & NEPHEW BACK UP WAS AVAILABLE FOR USE IF NEEDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8626425 ↗
• MalfunctionMay 8, 2019Break; Break

  IT WAS REPORTED THAT THE PRODUCT BROKE DURING IMPACTION. NO HARM TO PATIENT OR STAFF. NOTHING GOT IN PATIENT. NO PROCEDURAL DELAYS BECAUSE SMITH & NEPHEW BACK UP WAS AVAILABLE. PATIENT SURVIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8591298 ↗
• MalfunctionApr 8, 2019Fracture; Fracture

  IT WAS REPORTED THAT PIECE CHIPPED OFF DURING IMPACTING. PIECE REMOVED FROM PATIENT. NO HARM TO PATIENT OR STAFF. 2 MINUTE DELAY. SMITH & NEPHEW BACK UP AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8493883 ↗
• MalfunctionSep 7, 2018Break

  IT WAS REPORTED THAT DEVICE GET DAMAGED DURING SURGERY. THERE WAS NO AFFECTATION TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7854842 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122170. One submission often covers many models, so check the product and lot details in each record.

• Z-0351-2020 · Oct 7, 2019 · Terminated
  LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN nails are indicated for fractures of the femur including: simple shaft fractures, comminuted sha