NA 1896-5055SRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04546540202529), received between Nov 14, 2019 and Jun 29, 2026 — classified as 11 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (11 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJun 29, 2026Fracture; Material Deformation

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT SURGERY ON (B)(6) 2026, FOR A COMPLEX FRACTURE OF THE PROXIMAL FEMUR, TREATED WITH A LONG GAMMA4 NAIL. HE REMAINED NON-WEIGHT-BEARING FOR SIX WEEKS. A FOLLOW-UP X-RAY PERFORMED AT THAT TIME CONFIRMED THAT THE REDUCTION WAS STABLE AND THAT HEALING HAD BEGUN. WEIGHT-BEARING WAS THEN PERMITTED. HOWEVER, JUST ONE MONTH AFTER RESUMING WEIGHT-BEARING, THE PATIENT EXPERIENCED A FRACTURE OF THE OSTEOSYNTHESIS HARDWARE. UPON REVIEW OF THE PROVIDED X-RAYS, DEFORMATION OF ONE LOCKING SCREW WAS IDENTIFIED. HE WILL UNDERGO REOPERATION ON (B)(6) 2026 FOR A COMPLEX REVISION PROCEDURE INVOLVING THE REMOVAL OF THE FRACTURED NAIL, FOLLOWED BY A NEW OSTEOSYNTHESIS USING A LONG DCS PLATE COMBINED WITH A BONE GRAFT.

  Patient problems: Insufficient Information

  MAUDE report 25658433 ↗
• InjuryOct 9, 2025Fracture; Material Deformation; Fracture; Material Deformation

  AS REPORTED: "PATIENT WAS IMPLANTED WITH A 9MM 380MM T2 FEMORAL NAIL WHICH VERY RECENTLY FAILED WITH FRACTURED DISTAL LOCKING SCREWS AND FRACTURED PROXIMAL PORTION OF NAIL, BROKEN IMPLANT WAS REMOVED AND REVISED WITH A 11MM 360MM T2 ALPHA NAIL."

  Patient problems: Insufficient Information

  MAUDE report 23253726 ↗
• InjuryOct 6, 2025Fracture; Fracture

  IT WAS REPORTED THAT AFTER 6 MONTH, THE NAIL WAS REMOVED SINCE IT BROKE OFF AT THE CEPHALIC SCREW PART. 9/9/2025 - UPON PRODUCT RETURN ADDITIONAL DEVICES WERE RECEIVED INCLUDING ONE BROKEN LOCKING SCREW.

  Patient problems: Insufficient Information

  MAUDE report 23219780 ↗
• InjuryJun 30, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2017. THE SCREW INSERTED INTO THE T2GTN WAS BROKEN. REVISION SURGERY WAS PERFORMED (B)(6) 2025. THE IMPLANTS PREVIOUSLY INSERTED WERE REMOVED AND TRANSFERRED TO BHA. DURING SCREW REMOVAL, FRACTURE TO THE CORTICAL BONE OF THE FRAGMENT WAS CONFIRMED.".

  Patient problems: Bone Fracture(s)

  MAUDE report 22359306 ↗
• MalfunctionNov 6, 2024Positioning Failure; Material Fragmentation; Positioning Failure; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE SCREW WAS NOT SCREWED INTO THE NAIL. WHEN REMOVING IT, A METAL CHIP WAS FORMED. NO SCREW WAS INSERTED. 10/22/2024 - ADDITIONAL INFORMATION RECEIVED: THE PROCEDURE WAS COMPLETED WITHOUT REPLACING A SCREW IN THE PLACE WHERE IT WAS SUPPOSED TO BE PLACED. NO CONSEQUENCES FOR THE PATIENT.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 20625805 ↗
• InjuryApr 3, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "GAMMA 3 IMPLANTED 16 MONTHS AGO AND 100 DAYS LATER THE IMPLANT BROKE. SCREWS AT THE BOTTOM BROKE AND NAIL ALSO BROKE BY THE POINT WHERE THE LAG SCREW IS IMPLANTED. ENTIRE CONSTRUCT WAS REVISED AND PATIENT EXPERIENCED A SIMILAR EVENT 100 DAYS LATER."

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 19038217 ↗
• InjuryJan 16, 2024Break; Fracture; Break; Fracture

  AS REPORTED BY THE CUSTOMER, "BREAKAGE OF THE DISTAL SCREWS OF THE FEMORAL NAIL".

  Patient problems: Failure of Implant

  MAUDE report 18516526 ↗
• InjuryNov 23, 2022Break; Fracture; Break; Fracture

  A SCREW BREAKAGE WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 15851577 ↗
• InjuryNov 3, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "THE PATIENT HAD A GAMMA3 OPERATION ABOUT A YEAR AND A HALF AGO. NOW THE NAIL IS BROKEN. THE NAIL HAS NOW BEEN REMOVED AND A T2 ALPHA RECON WAS INSERTED (B)(6)2022." UPON PRODUCT RETURN, ONE LOCKING SCREW WAS ALSO FOUND BROKEN. ADDITIONALLY, THE PATIENT HAD PAIN IN HER HIP, A CT-SCAN WAS PERFORMED AND IT WAS NOTICED THAT THE NAIL WAS BROKEN.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 15721332 ↗
• InjuryAug 23, 2021Fracture; Fracture

  AS REPORTED: "THE PATIENT PRESENTED WITH A BROKEN NAIL AND NON-UNION ONE YEAR AFTER INITIAL IMPLANTATION. REVISION SURGERY IS REQUIRED. NO DATE PLANNED ON INTAKE." UPDATE: CONTINUED PAIN IN LEFT HIP WHEN IN CLINIC APRIL. ADDED PAIN DURING WEIGHT BEARING ACTIVITY. LOCKING SCREW WAS NOTICED TO BE BROKEN ON THE X-RAY.

  Patient problems: Failure of Implant; Implant Pain; Nonunion/Delayed-union Bone Fracture

  MAUDE report 12356286 ↗
• MalfunctionJan 13, 2021Failure to Align; Failure to Align

  AS REPORTED: "DURING THE PROCEDURE, REDUCTION OF THE FEMUR FRACTURE WITH A GAMMA TI NAIL, PERFORMED AT THE LEÓN XIII CLINIC, WHEN THE IMPLANT WAS PLACED IN THE DISTAL LOCKING HOLE, THE SCREW REMAINED ROLLED, AS IT WAS NOT FIXED TO THE BONE OR THE NAIL, IT WAS DECIDED TO CHANGE OF IMPLANT AND THIS SECOND IF IT IS FIXED CORRECTLY.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11167974 ↗
• InjuryApr 16, 2020Fracture; Fracture

  AS REPORTED: "AFTER FIXATION OF T2GTN, THE DISTAL SCREW BROKE." ADDITIONALLY REPORTED: "THE REVISION WAS MADE ON MARCH 23, AND ALL NAIL AND SCREWS WERE REMOVED. SINCE BONE FUSION WAS OBTAINED, IT WAS ONLY REMOVAL."

  Patient problems: Failure of Implant; Injury

  MAUDE report 9967470 ↗
• InjuryNov 14, 2019Fracture; Fracture; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2019, BIKE ACCIDENT. ON (B)(6) 2019, GAMMA3 NAIL IMPLANTED. ON (B)(6) 2019, REVISION SURGERY. PATIENT VISITED HOSPITAL AFTER PAIN.

  Patient problems: Injury; Pain

  MAUDE report 9324279 ↗