TRIGEN 71642690Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556132975), received between Apr 20, 2021 and Nov 7, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

3 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.

Recalls naming this device

1. Mar 18, 2025Open, Classified

   Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.

   Z-1806-2025 · Root cause: Process control · Recall details · FDA record ↗

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.

• InjuryNov 7, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A META-TAN SCREW PLANNED REMOVAL, THE BACK END OF THE META-TAN LAG/COMPRESSION SCREW 90MM/85MM FRACTURED OFF. AFTER A DELAY OF MORE THAN 30 MIN, THE SCREW COULD NOT BE REMOVED, IT REMAINS IN THE PATIENT. NO ADDITIONAL INTERVENTION IS PLANNED TO REMOVE THE SCREW FROM HIS BODY. PATIENT'S CURRENT HEALTH STATUS IS GOOD.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18084706 ↗
• InjuryAug 17, 2022Break; Break

  IT WAS REPORTED THAT, DURING SURGERY OF NAIL REMOVAL (PLANNED SURGERY), WHEN REMOVING'S THE LAG SCREW, THE TIP OF THE TWO (2) META-TAN LAG SCREW DRIVER WERE BROKEN. USING OTHER TOOL SCREW EXTRACTOR SIZE 1, THE SURGERY WAS COMPLETED, BUT ALSO IT WAS BROKEN WHEN IT WAS REMOVED FROM THE EXPLANTED LAG SCREW. DEVICE INSIDE THE PATIENT. PIECES FELL INSIDE THE PATIENT AND IT IS UNKNOWN IF/HOW THE PIECES WERE EXTRACTED. THE PROCEDURE WAS COMPLETED USING A S+N BACK-UP DEVICE. SURGERY WAS 30 MIN DELAYED. PATIENT WAS NOT HARMED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15245681 ↗
• InjuryApr 20, 2021Break; Break

  IT WAS REPORTED THAT, DURING A PLANNED SURGERY OF META-TAN REMOVAL, IT WAS DIFFICULT TO REMOVE THE META-TAN NAIL WITH AN UNKNOWN META-TAN LAG SCREW DRIVER ((B)(4)). THEREFORE, META-TAN LAG SCREW DRIVER WAS CHANGED TO EASY OUT SMALL . THE NAIL WAS REMOVED, BUT PART OF AN UNKNOWN LAG SCREW ((B)(4)) AND THE EASY OUT SMALL ((B)(4)) BROKE INSIDE THE PATIENT. ALL PIECES WERE REMOVED. THE PROCEDURE WAS COMPLETED WITH A LESS THAN 30 MINS DELAY USING THE SAME DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11696358 ↗

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-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