NA 2361-5080SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327381580), received between Jul 28, 2022 and May 2, 2025 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 2, 2025Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED: "PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2025. TWO WEEKS AFTER THE PRIMARY SURGERY, TWO DISTAL SCREWS (ALS) BAKED OUT. REVISION SURGERY FOR REINSERTION WAS PERFORMED ON (B)(6) 2025."

  Patient problems: Insufficient Information

  MAUDE report 21952180 ↗
• InjuryMay 2, 2025Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED: "PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2025. TWO WEEKS AFTER THE PRIMARY SURGERY, TWO DISTAL SCREWS (ALS) BAKED OUT. REVISION SURGERY FOR REINSERTION WAS PERFORMED ON (B)(6) 2025."

  Patient problems: Insufficient Information

  MAUDE report 21952000 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "ORIF WAS PERFORMED FOR FEMORAL CONDYLE FRACTURE ON (B)(6) 2024. HOWEVER, IT WAS FOUND THAT FIXATION WAS NOT ACHIEVED ON (B)(6) 2024. THUS, REVISION SURGERY TO REMOVE THE DEVICES WAS PERFORMED ON (B)(6) 2024. THE DOCTOR TOLD THAT THE ORIGINAL FRACTURE WAS SEVERE, AND ALTHOUGH THE DEVICES WERE IMPLANTED IN HOPES OF REDUCING AND MAINTAINING THE FRACTURE, THE FRACTURE PART REMAINED UNSTABLE AFTER SURGERY."

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 19027457 ↗
• InjuryNov 15, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT A T2 ALPHA RETROGRADE NAIL WAS DISCOVERED TO BE BROKEN AT THE MOST PROXIMAL SCREW HOLE IN THE DISTAL CLUSTER OF THE NAIL. THE SCREW WAS FOUND TO BE BROKEN DURING EXPLANTATION OF THE NAIL. PATIENT WAS GIVEN WEIGHT BEARING AS TOLERATED INSTRUCTIONS POSTOPERATIVELY. PATIENT WAS REVISED TO A T2 SCN WITH ENDCAP. PRIMARY IMPLANT DATE WAS (B)(6) 2022. PATIENT TOOK NOTICE ON (B)(6), AFTER FALLING DOWN AND FEELING PAIN. NAIL HAS BEEN RETURNED.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 15796659 ↗
• InjuryNov 8, 2022Migration; Migration

  IT WAS REPORTED THAT THERE WAS A DISTAL SCREW MIGRATION WITH SUBSEQUENT NAIL BREAKAGE WHICH RESULTED IN A REVISION SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 15754903 ↗
• MalfunctionJul 28, 2022Migration; Migration

  AS REPORTED: "ADVANCED LOCKING SCREWS BACKING OUT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15120469 ↗