TRIGEN 71645065Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556216293), received between Aug 5, 2020 and Apr 3, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

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

• InjuryApr 3, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, A TRIGEN LOW PROFILE SCREW 5.0MM X 65MM BECAME HARD TO TURN JUST BEFORE THE SCREW HOLE. THEN A NOISE WAS HEARD, AND THE SCREW COULD NOT BE INSERTED. SO, IT WAS REMOVED AND DRILLING WAS PERFORMED AGAIN, BUT THE SAME ISSUE OCCURRED. AFTER THIS, THE SURGEON GAVE UP SCREW INSERTION; AND THE PROCEDURE WAS FINISHED WITH A FIVE MINUTE DELAY, WITHOUT A BACK UP. IT WAS CONFIRMED THAT ALL THE INSTRUMENTS HAD BEEN ALIGNING CORRECTLY IN ORDER TO INSERT THE ORIGINAL SCREW INTO THE INTENDED POSITION. AN ADDITIONAL SCREW WAS PLACED AT ANOTHER POSITION TO COMPENSATE FOR THIS ISSUE. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN, BUT IT WAS REPORTED THAT BONE QUALITY WAS NORMAL.

  Patient problems: Rupture

  MAUDE report 16668658 ↗
• InjuryJul 7, 2021Unintended Ejection; Unintended Ejection

  IT WAS REPORTED THAT, DURING FOLLOW UP AFTER AN INTERNAL FIXATION PROCEDURE, IT WAS EVIDENT THAT A TRIGEN LOW PROFILE SCREW 5.0MM X 65MM WAS LOOSE AND OUTSIDE THE NAIL. THE SCREW WAS REMOVED FROM THE HIND FOOT NAIL AND THE SYSTEM WAS LEFT IN THIS WAY PENDING THE CONSOLIDATION OF THE FRACTURE. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12130119 ↗
• InjuryApr 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING FUSION NAIL PROCEDURE, THE LOCKING SYSTEM OF THE NAIL SYSTEM WAS WORKING CORRECTLY. THE IMPLANTATION AND THE POSTERIOR DISTAL LOCKING WERE CARRIED OUT. AT THE END OF THE PROCEDURE, THE POSTOPERATIVE RADIOGRAPHS WERE REVIEWED AND A SCREW WAS NOTICED TO BE OUTSIDE THE DISTAL LOCKING SYSTEM OF THE NAIL.

  Patient problems: Failure of Implant

  MAUDE report 11612128 ↗
• InjuryDec 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN A REVISION SURGERY THAT THE NAIL EXCHANGE DUE TO NON UNION (MID-SHAFT). THE PATIENT OUTCOME IS UNKNOWN. THE SURGEON DID NOT BLAME THE DEVICE AND HE WAS SATISFIED WITH THE SURGICAL OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10953758 ↗
• InjuryAug 5, 2020Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT UNDERWENT META-TAN SURGERY ON (B)(6) 2018. THE PATIENT VISITED THE HOSPITAL ON (B)(6) 2020 AND AFTER X-RAY IMAGES WERE REVIEWED, WAS FOUND THAT THE PROXIMAL SCREW BROKE OFF. IN AN IMAGE TAKEN ON (B)(6) 2018, THE SCREW WAS SUSPECTED OF BREAKAGE, AND IN ANOTHER IMAGE TAKEN ON (B)(6) 2018, THE SCREW WAS OBVIOUSLY BROKEN. A REVISION SURGERY IS PLANNED AND SCHEDULED ON (B)(6) 2020, FOR REPLACEMENT OF THE TRIGEN LOW PROFILE SCREW 5.0MM X 65MM.

  Patient problems: Injury

  MAUDE report 10369092 ↗

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