TRIGEN 71645035Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00885556215692), received between Mar 17, 2019 and Nov 26, 2024 — classified as 8 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2024Crack; Crack

  IT WAS REPORTED THAT, DURING THR SURGERY, AS SURGEON WAS IMPLANTING THE FINAL DISTAL INTERLOCK TRIGEN LOW PROFILE SCREW 5.0MM X 35MM, RIGHT AS IT WAS FULLY DOWN, THE HEAD OF THE SCREW CRACKED. SURGEON DID NOT REMOVE THE SCREW AS IT WAS IN A SUFFICIENT POSITION TO LEAVE IN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20784867 ↗
• MalfunctionJul 7, 2023Difficult to Insert; Peeled/Delaminated; Difficult to Insert; Peeled/Delaminated

  IT WAS REPORTED THAT, DURING SURGERY AN INTERNAL FIXATION SURGERY, WHILE INSERTING ONE (1) TRIGEN LOW PROFILE SCREW 5.0MM X 35MM INTO THE SECOND DISTAL SCREW HOLE OF ONE (1) META-TAN 9MM X 30CM RIGHT, IT WAS FOUND THAT THE SCREW PASSED THE OUTSIDE BUT STOPPED AT INSIDE. REPEATED ATTEMPTS TO DRILL AGAIN DID NOT RESOLVE THE PROBLEM. IT WAS CONFIRMED THAT THERE WAS NO TECHNIQUE ERROR, AND THAT THE SCREW WAS NOT INSERTED. THE PROCEDURE WAS RESUMED, AFTER 10 MINUTES SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17283423 ↗
• InjuryJun 11, 2022Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE LEFT INTERTAN NAIL AND THE SINGLE SLIDING TRIGEN LOW PROFILE SCREW WERE PLACED. THE DISTAL LOCKING WAS PERFORMED IN THE HOLE AND THE TRIGEN LOW PROFILE SCREW STOPPED ADVANCING APPROXIMATELY 7MM TO REACH THE SECOND CORTEX. THE SCREW HEAD SEPARATED AND DID NOT ALLOW ADVANCEMENT. THE PHYSICIAN DECIDED TO RETRIEVE THE FRAGMENT WITH AN ADJUSTABLE PRESSURE FORCEPS BUT SCREW HEAD BROKE. THE SHAFT OF THE SCREW WAS LEFT INSIDE THE BONE PASSING THROUGH THE NAIL LOCKING HOLE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITHOUT SIGNIFICANT DELAYS. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant; Foreign Body In Patient

  MAUDE report 14670559 ↗
• InjuryDec 7, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT, AFTER AN INTERTAN SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED PAIN POST SURGERY. THE X-RAYS SHOWED BACKING OUT OF THE COMPRESSION SCREW USED WITH AN INTERTAN DEVICE WHICH WAS LOCKED WITH THE SET SCREW. ALSO, THE SURGICAL TEAM ARE STILL DECIDING ON APPROPRIATE TREATMENT FOR THE PATIENT. IT IS UNKNOWN HOW THE ADVERSE EVENT WAS SOLVED AND CURRENT HEALTH STATUS OF PATIENT.

  Patient problems: Failure of Implant; Pain

  MAUDE report 12953204 ↗
• InjurySep 14, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, A TRIGEN LOW PROFILE SCREW 5.0MM X 35MM WAS HARD TO INSERT COMPLETELY, THE SURGEON APPLIED STRONG FORCE AND CAUSED THE SCREW HEAD BROKE OFF (IT WAS FIXED TO THE SCREW DRIVER SO IT DID NOT FELL INSIDE THE PATIENT). THREADED PART OF THE SCREW REMAINED INSIDE THE PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12471991 ↗
• 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: Awareness During Anesthesia; Bacterial Infection

  MAUDE report 11817078 ↗
• InjuryMay 13, 2021Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  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 07-APR-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 UNKNOW.

  Patient problems: Abrasion; Bacterial Infection

  MAUDE report 11817058 ↗
• InjuryApr 19, 2021Break; Break

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY THAT HAD BEEN PERFORMED ON 12-FEB-2021, THE INTERTAN 10S 10MM X 18CM 125D NAIL FRACTURED ON 16-FEB-2021. A REVISION SURGERY WAS PERFORMED ON 24-MAR-2021 TO EXPLANT THE NAIL SYSTEM. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 11685228 ↗
• MalfunctionNov 13, 2019Break; Break

  IT WAS REPORTED THAT THE ITEM BROKE AT THE POINT OF THE LAG/COMPRESSION SCREW COMBO. IT BROKE INSIDE THE PATIENT, AND ALL PIECES WERE RECOVERED. BACK-UP USED TO COMPLETE THE PROCEDURE. NO DELAY OR INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9318110 ↗
• InjuryMay 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO UNSPECIFIED REASONS.

  Patient problems: Injury

  MAUDE report 8609098 ↗
• InjuryMar 17, 2019Break; Break

  IT WAS REPORTED THAT AN UPCOMING REVISION SURGERY IS SCHEDULED FOR THE PATIENT DUE TO BREAKAGE OF THE NAIL. DETAILS OF REVISION ARE UNAVAILABLE. FOUR DEVICES WERE EXPLANTED, ACCORDING TO X-RAYS ATTACHED AND DEVICES RECEIVED.

  Patient problems: Injury

  MAUDE report 8427361 ↗

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