NA 1806-6160Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540509994), received between Nov 16, 2018 and Mar 4, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2025Material Deformation; Material Deformation

  AS REPORTED: "THE THREADS ON THE CONNECTION BETWEEN THE UNIVERSAL ROD AND THE EXTRACTION HOOK HAVE BECOME DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21520624 ↗
• MalfunctionOct 6, 2023Break; Fracture; Mechanical Jam; Break; Fracture; Mechanical Jam

  AS REPORTED: "THE TIP OF THE EXTRACTION HOOK WAS BROKEN OFF DURING EXTRACTION OF THE FRACTURED NAIL AND THE METAL PIECE IS RETAINED IN THE PATIENT BODY." UPDATE- IT WAS ADDITIONALLY REPORTED THAT THERE WAS A 60 MINUTE SURGICAL DELAY.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17884969 ↗
• MalfunctionJun 19, 2023Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT WHEN EXTRACTING THE BROKEN TIP OF A GAMMA NAIL, AN EXTRACTION HOOK WAS USED, BUT THE TIP BENT AND BECAME UNUSABLE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17151498 ↗
• MalfunctionApr 14, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "DURING AN EXTRACTION OF A T2A-GT NAIL, THE HOOK PART BROKE DURING THE PROCESS AND WAS RETAINED IN THE BODY OF PATIENT."

  Patient problems: Foreign Body In Patient

  MAUDE report 16743072 ↗
• MalfunctionNov 16, 2018Break; Entrapment of Device; Device Damaged by Another Device; Material Twisted/Bent

  AFTER THE PROXIMAL BROKEN NAIL AND LAG SCREW WERE REMOVED, EXTRACTION HOOK (18066160) WAS HANGED TO THE DISTAL PART OF NAIL AND HIT WITH HAMMER AND ABOUT 1MM OF THE TIP OF THE EXTRACTION HOOK WAS LACKED AND THE IT WAS NOT ABLE TO BE HANGED TO NAIL. THEREFORE, NEW HOOK WAS USED, BUT THE TIP OF THE HOOK WAS BENT AFTER IT WAS HIT WITH HAMMER AND NOT ABLE TO BE USED. THEREFORE, THE DISTAL PART OF THE NAIL AND BROKEN HOOK WAS LEFT IN THE PATIENT BODY AND OPERATION WAS FINISHED. REMOVAL OF NAIL REMAINED IN THE PATIENT'S BODY WAS DONE. HOWEVER, THE DISTAL PART OF THE NAIL WAS NOT REMOVED AND IT WAS LEFT AND CHS IMPLANT (SYNTHES) WAS DEPLOYED. REVISION # 2 REPORTED UNDER SEPARATE PI.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8081169 ↗