TRIGEN 71642600Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556133088), received between Aug 6, 2020 and Aug 11, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K092748, K210980); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2021Mechanical Jam; Osseointegration Problem; Mechanical Jam; Osseointegration Problem

  IT WAS REPORTED THAT, AFTER SURGERY HAD BEEN PERFORMED ON (B)(6) 2019, AND BEFORE A TRIGEN META TAN REMOVAL, IT WAS DISCOVERED THAT IS NOT POSSIBLE TO REMOVE THE LAG SCREW OUT DUE TO NO INSERTION OF A COMPRESSION SCREW. IT WAS REPORTED THAT THE EVENT WILL NOT BE SOLVED IN ORDER TO PROTECT THE PATIENT FROM RE-FRACTURING THE FEMUR. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12311048 ↗
• InjuryJul 1, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT AFTER AN INTERNAL FIXATION SURGERY, PERFORMED ON (B)(6) 2021, SCREWS OF META-TAN LAG/COMP KIT 100/95 ((B)(4)) WERE USED THROUGH AN INTERTAN 11.5MM X 20CM 125D ((B)(4)), LEADING TO EARLY IMPLANT FAILURE. WITH SOME FURTHER INVESTIGATION, IT WAS DISCOVERED THAT THERE WAS NO SALES REP PRESENT AT THE ORIGINAL OPERATION, AND THE ERROR WAS MADE BY A JUNIOR CLINICIAN AT POINT OF SURGERY. THE SURGEON AND HOSPITAL DO NOT BLAME THE IMPLANTS AT ALL, AND THE METATAN SCREWS HAVE NOW BEEN MORE CLEARLY LABELLED FOR FUTURE REFERENCE. THIS ISSUE WAS RESOLVED WITH A REVISION PERFORMED ON (B)(6) 2021.

  Patient problems: Failure of Implant

  MAUDE report 12105181 ↗
• InjuryAug 6, 2020Break; Break

  IT WAS REPORTED THAT DURING A PLANNED SURGERY FOR NAIL REMOVAL, THE THREADED PART OF THE DEVICES DEFORMED/BROKE. THE TIPS FROM THE DEVICES DO NOT REMAIN IN THE PATIENT'S BODY, HOWEVER THE SLOTTED PART OF THE LAG SCREW ALSO BROKE OFF AND THE PIECES REMAIN INSIDE THE PATIENT BODY. IT WAS ATTEMPTED TO REMOVED THE PIECES USING AN EASY OUT BUT IT DID NOT MATE TO THE LAG SCREW. THE PROCEDURE WAS CONCLUDED WITHOUT REMOVING THE NAIL AND LAG SCREW. THE PIECES FROM LAG SCREW REMAINS. A 60 MIN DELAY WAS REPORTED. PATIENT OUTCOME IS UNKNOWN. 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 10376753 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092748, K210980. One submission often covers many models, so check the product and lot details in each record.

• Z-2456-2026 · Mar 16, 2026 · Open, Classified
  TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
• Z-1806-2025 · Mar 18, 2025 · Open, Classified
  META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
• Z-2443-2023 · Jul 24, 2023 · Open, Classified
  TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
• Z-2444-2023 · Jul 24, 2023 · Open, Classified
  TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail