TRIGEN 71656000Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010585417), received between Sep 27, 2018 and Nov 28, 2022 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 28, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE META-NAIL CAP SET SCREW 0MM WAS PLACED AND IT BROKE AT THE HEAD OF THE PLUG, REMAINING INSIDE THE INTRAMEDULLARY NAIL, IT WAS POSSIBLE TO EXTRACT A PART OF THE FRAGMENT OF THE PLUG. THE DEVICE WAS LOCATED INSIDE THE PATIENT AT THE MOMENT OF THE ISSUE. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS LESS THAN OR EQUAL TO 30 MINS DELAYED. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15870186 ↗
• InjurySep 10, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, AT THE TIME OF PLACING THE TRIGEN META-NAIL NAIL CAP SET SCREW 0MM, IT BROKE, BECAUSE TOO MUCH FORCE WAS EXERTED. AN ATTEMPT WAS MADE TO REMOVE THE CAP BUT THIS ALREADY HAD ALL THE THREAD INSIDE THE NAIL. A PART OF THE CAP REMAINED OUTSIDE, SO IT WAS BROKEN IN SUCH WAY, TO LEAVE IT AT THE SAME LEVEL AS THE NAIL, SO IT DOES NOT GENERATE DISCOMFORT TO THE PATIENT. SURGERY WAS PERFORMED WITH THE SAME DEVICE, IT IS UNKNOWN IF THERE WAS ANY DELAY ON THE SURGERY. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 12452618 ↗
• MalfunctionJan 13, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING SURGERY, AT THE TIME OF PUTTING THE TIBIA NAIL PLUG THE THREAD DOES NOT ALLOW ITS POSITIONING. THE PATIENT WAS LEFT WITHOUT THE CAP. NO BACK UP DEVICE WAS AVAILABLE. DELAY GREATER THAN 30 MIN IN THE PROCEDURE AND NO INJURY TO PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9580246 ↗
• MalfunctionDec 2, 2019Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SURGERY THE NAIL WAS PLACED CORRECTLY AND AT THE TIME OF SECURING WITH THE PLUG, THIS DIDN´T FIT WITH THE NAIL. IT WAS DECIDED TO LEAVE THE PATIENT WITHOUT A CLOSURE CAP. NO DAMAGE TO PATIENT OCCURRED. DELAY GREATER THAN 30 MIN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9395856 ↗
• MalfunctionNov 12, 2018Break; Break

  IT WAS REPORTED THAT THE REDUCTION OF THE FRACTURE WAS PERFORMED WITHOUT ANY PROBLEM. THE NAIL WAS PASSED IN THE CORRECT WAY AND ITS DISTAL BLOCKS WERE MADE WITHOUT ISSUES WITH THE SURE SHOT, LIKEWISE THE PROXIMAL ONES WITH THE DEVICE. WHEN THE CAP (0 MM ) WAS PLACED, THIS WAS PLACED IN THE CORRECT WAY AND IT WAS PRESSED INTO THE NAIL, BUT WHEN WE WERE CHECKING WITH THE INTENSIFIER, WE COULD SEE THAT THE CAP WAS MISSING A LITTLE MORE TO ENTER. WHEN THE DOCTOR PASSES THE SCREWDRIVER, WE NOTICE THAT THE CAP WAS BROKEN AS 2 LINES OF THE THREAD, THAT COMPLETE THREAD WAS REMOVED BY BITS AND MORE THAN HALF OF THE CAP WAS INSIDE THE NAIL, WITHOUT CAUSING PROBLEMS TO THE DEVICE, OR THE PATIENT. THE SURGICAL PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8062090 ↗
• MalfunctionSep 27, 2018Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE SURGEON REQUESTED A CAP (0MM) IN ORDER TO PLACE IT AFTER WE FINISHED WITH THE LOCKS, ASSEMBLY WAS MADE WITH THE CORRESPONDING SCREWDRIVER, AT THE MOMENT OF SCREWING THE CAP IN THE NAIL, THE CAP WAS BROKEN IN THE HEAD, PREVENTING IT FROM BEING SCREWED IN THE NAIL. IN ADDITION TO THAT THE SCREWDRIVER WAS STUCK IN THE CAP AND IT COULD NOT BE REMOVED FROM IT. THE DOCTOR DECIDED NOT TO PUT THE CAP.

  Patient problems: No Information

  MAUDE report 7917254 ↗