TRIGEN 71634000Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010495709), received between May 29, 2019 and Aug 12, 2025 — classified as 1 injury, 4 malfunctions.

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

6 other recalls cover devices cleared under the same FDA submission (K210980, K981529); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN ORIF SURGERY, ONE (1) NAIL CAP {} 0MM WAS INSERTED AT THE CORRECT ANGLE, BUT IT DID NOT FULLY ENGAGE AND BACKED OUT. AFTER SEVERAL ATTEMPTS AT DIFFERENT ANGLES AND WITH INCREASED FORCE, THE EDGE OF THE NAIL CAP {} 0MM, WHERE IT ATTACHES TO THE KEY, BROKE MAKING ITS REMOVAL IMPOSSIBLE. THE PROCEDURE WAS RESUMED WITHOUT DELAY USING THE SAME DEVICE, AND NO INJURIES WERE REPORTED AS A RESULT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22787684 ↗
• MalfunctionJun 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN OSTEOSYNTHESIS PROCEDURE, AT THE END OF FIXING THE NAIL CAP {} 0MM, IT WAS DECIDED TO PLACE A CAP PROXIMAL TO THE NAIL. HOWEVER, WHEN ADJUSTING THE THREAD TO THE NAIL, IT BROKE AND DID NOT ALLOW FOR EASY REMOVAL. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22123444 ↗
• MalfunctionNov 11, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING PROCEDURE WHEN THE TIBIAL INTRAMEDULLARY NAIL WAS FINALLY PUT ON THE NAIL CAP, THERE WAS A PROBLEM WITH THE THREAD OF THE NAIL CAP, WHICH COULD NOT BE SCREWED IN. SURGERY WAS COMPLETED WITH AN S+N BACKUP DEVICE. NO INFORMATION ABOUT INJURIES OR SURGICAL DELAYS WERE REPORTED.

  Patient problems: Insufficient Information; No Known Impact Or Consequence To Patient

  MAUDE report 10826068 ↗
• InjuryNov 11, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING PROCEDURE WHEN THE TIBIAL INTRAMEDULLARY NAIL WAS FINALLY PUT ON THE NAIL CAP, THERE WAS A PROBLEM WITH THE THREAD OF THE NAIL CAP, WHICH COULD NOT BE SCREWED IN. SURGERY WAS COMPLETED WITH AN S+N BACKUP DEVICE. NO INFORMATION ABOUT INJURIES OR SURGICAL DELAYS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10825980 ↗
• MalfunctionMay 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING PROCEDURE, WHEN THE CAP WAS SCREWED ON THE NAIL IMPLANTED ON THE PATIENT THE CAP BEGAN TO CRACK ON THE HEAD UNTIL IT WAS BROKEN. DELAY WAS NOT SPECIFIED. NO INJURY REPORTED. DOCTOR DECIDED TO LEAVE THE NAIL WITHOUT CAP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8651734 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K210980, K981529. 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
• Z-0943-2013 · Feb 7, 2013 · Terminated
  INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 80 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for
• Z-0944-2013 · Feb 7, 2013 · Terminated
  INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 75 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for