TRIGEN 71645040Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00885556215791), received between Apr 21, 2018 and Feb 25, 2022 — classified as 9 injuries, 1 malfunction.

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TRAUMA SURGERY WAS PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A FRACTURE OF THE NECK OF THE FEMUR. THIS ADVERSE EVENT WAS SOLVED WITH A REVISION SURGERY ON (B)(6) 2022, REMOVING THE TRIGEN LOW PROFILE SCREW 5.0MM X 40MM. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Vertebral Fracture

  MAUDE report 13602283 ↗
• InjuryJan 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TRAUMA SURGERY HAD BEEN PERFORMED ON 2019, THE PATIENT EXPERIENCED A NON-UNION OF A SUBTROCANTHERIC FRACTURE. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY PERFORM ON (B)(6) 2021, IN WHICH THE META-TAN 10MM X 36CM RIGHT, AND THE SET OF SCREWS: TRIGEN LOW PROFILE SCREW 5.0MM X 40MM, TRIGEN LOW PROFILE SCREW 5.0MM X 45MM AND META-TAN LAG/COMP KIT 95/90 WERE EXPLANTED. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. IT IS SUSPECTED THAT PATIENT HAS A BONE DISEASE BECAUSE SHE HAS A COUPLE OF FRACTURES CAUSED BY LOW ENERGY FORCES.

  Patient problems: Failure of Implant

  MAUDE report 13152474 ↗
• InjuryMay 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DUE TO A FALL ON (B)(6) 2020, A PATIENT EXPERIENCED A RIGHT TIBIAL FRACTURE WHICH REQUIRED A TEMPORARY TREATMENT WITH AN EXTERNAL FIXATOR ON (B)(6) 2020. THIS EXTERNAL FIXATOR WAS REMOVED ON (B)(6) 2020 AND AFTER A RIGHT TIBIAL INTERNAL INFIXATION SURGERY WITH TRIGEN LOW PROFILE SCREW 5.0MM X 35MM PERFORMED THE SAME DAY, THE PATIENT EXPERIENCED SECRETION AND WOUND HEALING PROBLEMS WITH THE PRESENCE OF STAPHYLOCOCCUS AUREUS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. THE TRIGEN LOW PROFILE SCREW 5.0MM X 35MM (X2), INT HEX CAP SCR 5.0MM X 35MM, TRIGEN LOW PROFILE SCREW 5.0MM X 40MM AND TRIGEN LOW PROFILE SCREW 5.0MM X 55MM WERE EXPLANTED DURING THIS REVISION SURGERY. IT IS UNKNOWN IF THE EXPLANTED DEVICE WAS SUBSTITUTED WITH A SMITH AND NEPHEW IMPLANT. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Abrasion; Bacterial Infection

  MAUDE report 11817084 ↗
• 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 10953810 ↗
• 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 10953472 ↗
• MalfunctionOct 29, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT DURING SURGERY THE HEAD OF THE TRIGEN LOW PROFILE SCREW 5.0MM X 40MM DID NOT MATE TO THE DRIVER. S&N BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO INJURY TO PATIENT. THERE WAS 10 MINUTES DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10756012 ↗
• InjuryAug 28, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, SEVEN (7) WEEKS AFTER AN INTERNAL FIXATION SURGERY THAT USED INTERTAN, THE TRIGEN LOW PROFILE SCREW 5.0MM X 40MM DID NOT SEAT RIGHT. A REVISION SURGERY WAS PERFORMED TO ADDRESS THIS ADVERSE EVENT; THE WHOLE SYSTEM WAS EXPLANTED. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant; Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10463934 ↗
• InjuryJan 10, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE SURGEON WAS DISTAL LOCKING USING THE PERFECT CIRCLE TECHNIQUE, TO DRILL THE HOLE. WHEN SURGEON WAS INSERTING THE SCREW HE NOTED THE IT WAS VERY DIFFICULT TO INSERT THE SCREW, AND IT STARTED TO SQUEAK. AN A-P X-RAY WAS TAKEN AND THE SURGEON NOTED THE HIS ALIGNMENT WAS NOT CORRECT FOR THE MIDDLE SCREW. THE SURGEON ATTEMPTED TO REMOVE SCREW, BUT IT WAS STRIPPED IN THE PROCESS. THE SURGEON THE ATTEMPTED TO USE PLIERS TO GRASP THE HEAD OF THE SCREW, WHICH ENDED UP BREAKING THE HEAD OF THE SCREW. THE SCREW WAS LEFT IN. THE SURGEON SAID THAT ONCE THE PATIENT WAS HEALED UP THEY WOULD REMOVE THE SCREW AND NAIL.

  Patient problems: Injury

  MAUDE report 9578213 ↗
• InjuryApr 21, 2018Break; Break

  IT WAS REPORTED THAT THE NAIL BROKE INSIDE THE BONE, PATIENT HAD INSTABILITY SO A REVISION SURGERY WAS PERFORMED AND THE NAIL WAS REMOVED.

  Patient problems: Limited Mobility Of The Implanted Joint

  MAUDE report 7449537 ↗
• InjuryApr 21, 2018Break; Break

  IT WAS REPORTED THAT THE NAIL BROKE INSIDE THE BONE, PATIENT HAD INSTABILITY, SO A REVISION SURGERY WAS PERFORMED AND THE NAIL WAS REMOVED.

  Patient problems: Limited Mobility Of The Implanted Joint

  MAUDE report 7449535 ↗

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