TRIGEN 71645030Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00885556215593), received between Dec 21, 2018 and Feb 7, 2025 — classified as 9 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Failure to Osseointegrate” (2 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2025Malposition of Device; Deformation Due to Compressive Stress; Malposition of Device; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING INTERNAL FIXATION SURGERY, WHEN ENGAGING ONE (1) TRIGEN LOW PROFILE SCREW 5.0MM X 30MM IN THE PROXIMAL PORTION OF THE META-NAIL RETROGRADE FEMORAL NAIL IT WAS NOTICED THROUGH X-RAY THAT THE SCREW WAS SITTING PROUD AND NOT PROPERLY FULLY ENGAGED IN THE NAIL. WHILE ENGAGING THE NAIL, THE HEAD STRIPPED AND WAS NOT ABLE TO GET IT OUT. THE PROCEDURE WAS COMPLETED BY CHANGE IN SURGICAL TECHNIQUE AFTER A SIGNIFICANT DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21339990 ↗
• InjuryJun 12, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING INTERNAL FIXATION SURGERY, THE WRONG SIZE OF SCREW FOR REAMING WAS USED. META-NAIL TIBIAL 8.5MM X 32CM SHALL USE 4.5MM SCREW BUT INSTEAD, ONE (1) TRIGEN LOW PROFILE SCREW 5.0MM X 30MM HAD BEEN OPENED AND USED. THE WRONG SCREW WAS STUCK INSIDE THE NAIL HOLE AND COULD NOT BE REMOVE FROM PATIENT. PROCEDURE WAS FINISHED WITH A CHANGE IN SURGICAL TECHNIQUE.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 17105525 ↗
• MalfunctionDec 11, 2022Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT, DURING THA SURGERY, THE TRIGEN LOW PROFILE SCREW 5.0MM X 30MM IN PACKAGE DID NOT MATCH TO THE LENGTH SPECIFIED ON THE LABEL. DEVICE WAS HANDLED, BUT NOT USED ON PATIENT. THE SURGERY WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15956537 ↗
• InjuryJul 11, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION WAS PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED EARLY COMPRESSION, CAUSING THE LAG/COMP SCREW KIT 90/85 TO BEGIN PULLING FROM THE HEAD OF THE FEMUR. THIS EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2022, IN WHICH THE INTERTAN 10S 10MM X 18CM 130D WAS REMOVED. DURING THE REMOVAL, THE TRIGEN LOW PROFILE SCREW 5.0MM X 30MM STRIPPED OUT. SEVERAL TECHNIQUES WERE USED FOR THE REMOVAL, INCLUDING DRIVING THE SCREW TO THE FAR CORTEX, FRACTURING THE FEMUR. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Bone Fracture(s); Failure of Implant; Insufficient Information

  MAUDE report 14974298 ↗
• InjuryDec 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED IN ORDER TO REMOVE A TRIGEN LOW PROFILE SCREW 5.0MM X 30MM FROM HFN BECAUSE, PER SURGEON'S DISCRETION, THE PATIENT DID NOT FULLY FUSE. THE SURGEON ELECTED TO DYNAMIZE THE NAIL AND THE SCREW REMOVED WAS IN THE STATIC HOLE. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12964757 ↗
• InjurySep 27, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT, AFTER TRAUMA SURGERY WAS PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED PAIN ON (B)(6) 2021. THIS ADVERSE EVENT WAS TREATED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2021. THE SURGEON DETERMINED THIS FAILURE WAS DUE TO A NON-UNION. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 12537508 ↗
• InjuryApr 7, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A FEMALE PATIENT ((B)(6) YEARS OLD) UNDERWENT A FRACTURE AROUND THE DISTAL SCREW AFTER AN INTERTAN IMPLANT PROCEDURE. THE DR. THINKS THE DIAMETER OF THE PART UNDER THE SCREW HEAD IS WIDE, AND THE DIAMETER OF THE DRILL IS NOT FIT FOR IT. XRAY AND CT IMAGES ARE AVAILABLE. IT IS NOT KNOWN HOW LONG AFTER IMPLANTATION THE FRACTURE OCCURRED.

  Patient problems: Bone Fracture(s)

  MAUDE report 9932917 ↗
• MalfunctionApr 7, 2020Break; Break

  IT WAS REPORTED THAT A FEMALE PATIENT 87 YEARS OLD UNDERWENT A FRACTURE AROUND THE DISTAL SCREW AFTER AN INTERTAN IMPLANT PROCEDURE. THE DR. THINKS THE DIAMETER OF THE PART UNDER THE SCREW HEAD IS WIDE, AND THE DIAMETER OF THE DRILL IS NOT FIT FOR IT. XRAY AND CT IMAGES ARE AVAILABLE. IT IS NOT KNOWN HOW LONG AFTER IMPLANTATION THE FRACTURE OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9932885 ↗
• InjuryApr 1, 2020Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT AFTER AN OPERATION WHERE THE TRIGEN LOW PROFILE SCREW 5.0MM X 30MM WAS IMPLANTED, A CT SCAN WAS PERFORMED AND THE CT IMAGE SHOWED AN INCOMPLETE FRACTURE AROUND THE LPSS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 9913133 ↗
• InjuryApr 1, 2020Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT AFTER AN OPERATION WHERE THE TRIGEN LOW PROFILE SCREW 5.0MM X 30MM WAS IMPLANTED, A CT SCAN WAS PERFORMED AND THE CT IMAGE SHOWED AN INCOMPLETE FRACTURE AROUND THE LPSS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 9912945 ↗
• InjuryFeb 14, 2020Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT DURING SURGERY, A SCREW DRIVER DID NOT CAPTURE THE SCREW. IT SEEMS THAT THE SCREW HOLE WAS ALREADY DAMAGED/LICKING BEFORE USING IT. PROCEDURE WAS COMPLETED USING A 35MM SCREW. NO HARM TO PATIENT. NO DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9711059 ↗
• InjuryDec 21, 2018Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A 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: Injury

  MAUDE report 8189013 ↗

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-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-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