TRIGEN 71645027Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00885556215548), received between Jan 4, 2018 and Nov 26, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Break” (3 reports).

5 other recalls cover devices cleared under the same FDA submission (K111025, K161264, 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryNov 26, 2025Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, WHEN INSERTING ONE (1) TRIGEN LOW PROFILE SCREW 5.0MM X 27.5MM, THE SCREW HEAD BECAME STRIPPED PREVENTING ROTATION. ATTEMPTS TO REMOVE THE SCREW USING PLIERS RESULTED IN FRACTURE OF THE SCREW HEAD, MAKING EXTRACTION DIFFICULT, THE FRACTURED HEAD WAS REMOVED. THE SURGEON DECIDED TO LEAVE THE SCREW INSIDE THE BODY. THE PROCEDURE WAS RESUMED, AFTER A 2 HOUR SURGICAL DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23657646 ↗
• InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING SURGERY, AFTER INSERTING THE TRIGEN LOW PROFILE SCREW 5.0MM X 27.5MM, AN INCOMPLETE BONE FRACTURE WAS IDENTIFIED. THE PROCEDURE WAS RESUMED WITHOUT DELAY, USING THE SAME DEVICE.

  Patient problems: Bone Fracture(s)

  MAUDE report 21174990 ↗
• InjuryApr 8, 2020Fracture; Fracture

  IT WAS REPORTED THAT A FEMALE PATIENT HAD AN INTERTAN SURGERY. AFTER THE SURGERY SURGEON FOUND OUT THERE WAS FRACTURE AROUND DISTAL SCREWS, HE THINKS THE DIAMETER OF THE PART UNDER THE SCREW HEAD IS WIDE AND THE DIAMETER OF DRILL IS NOT FIT FOR IT.

  Patient problems: Injury

  MAUDE report 9938481 ↗
• InjuryApr 8, 2020Fracture; Fracture

  IT WAS REPORTED THAT A FEMALE PATIENT HAD AN INTERTAN SURGERY. AFTER THE SURGERY SURGEON FOUND OUT THERE WAS FRACTURE AROUND DISTAL SCREWS, HE THINKS THE DIAMETER OF THE PART UNDER THE SCREW HEAD IS WIDE AND THE DIAMETER OF DRILL IS NOT FIT FOR IT.

  Patient problems: Injury

  MAUDE report 9938149 ↗
• InjuryNov 5, 2019Break; Break

  IT WAS REPORTED THAT AFTER SURGERY THE SURGEON FOUND A SHADOW IN A X-RAY IMAGE. AFTER RECONFIRMING THE IMAGE, HE FOUND SOMETHING REMAINED. THEN THE SAME SURGERY WAS PERFORMED AGAIN USING OTHER IMPLANTS/DEVICES. AFTER PULLING OUT THE NAIL PREVIOUSLY IMPLANTED, A METALLIC PIECE WAS REMOVED FROM THE MEDULLARY SPACE. THEN REMOVING THE METAL MATERIALS AS MUCH AS POSSIBLE, THE SURGERY WAS COMPLETED BY IMPLANTING OTHER NAIL. BACK-UPS AVAILABLE. DELAY GREATER THAN 30 MIN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9281441 ↗
• InjuryOct 30, 2019Break; Break

  IT WAS REPORTED THAT AFTER SURGERY THE SURGEON FOUND A SHADOW IN A X-RAY IMAGE. AFTER RECONFIRMING THE IMAGE, HE FOUND SOMETHING REMAINED. THEN THE SAME SURGERY WAS PERFORMED AGAIN USING OTHER IMPLANTS/DEVICES. AFTER PULLING OUT THE NAIL PREVIOUSLY IMPLANTED, A METALLIC PIECE WAS REMOVED FROM THE MEDULLARY SPACE. THEN REMOVING THE METAL MATERIALS AS MUCH AS POSSIBLE, THE SURGERY WAS COMPLETED BY IMPLANTING OTHER NAIL. BACK-UPS AVAILABLE. DELAY GREATER THAN 30 MIN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9255828 ↗
• InjuryFeb 11, 2019Break; Break

  IT WAS REPORTED THAT PATIENT WHO HAD INTERTAN OPERATION ON (B)(6) 2017 AT THIS HOSPITAL HAD PAIN AND TOOK X-RAY AT OTHER HOSPITAL, THEN IT WAS NOTED THAT THE NAIL WAS BROKEN. REVISION SURGERY (BHR) WIL BE PERFORMED.

  Patient problems: Pain

  MAUDE report 8329830 ↗
• InjuryDec 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO FRACTURE. THE FRACTURE STARTED AT DISTAL SCREW SITE. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2018. (ABOUT 1 WEEK AGO) THE COMPLAINT IMPLANTS WERE NOT AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 8181554 ↗
• InjuryJan 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IF WAS REPORTED A PARTIAL BONE FRACTURE DURING SURGERY WHILE INSERTING THE LPS AT THE DISTAL FEMORAL

  Patient problems: Bone Fracture(s)

  MAUDE report 7166063 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111025, K161264, 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-2444-2023 · Jul 24, 2023 · Open, Classified
  TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail
• 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-1132-2013 · Mar 6, 2013 · Terminated
  TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN 38116 USA orthopedic surgery