T2 1806-3203Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540708458), received between Jun 11, 2021 and Sep 23, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2022Residue After Decontamination; Residue After Decontamination

  AS REPORTED: "AT THE START OF THE MEDICAL PROCEDURE IN THIS CLINIC, THE BLOODY NAIL HOLDING SCREW 1806-3203 (LOANER) FROM THE LAST SURGERY OF THE PREVIOUS PATIENT WAS STILL IN THE NAIL HOLDING ADAPTER 1806-3211. THIS WAS OVERLOOKED DURING THE KIT INSPECTION, AND A NEW NAIL HOLDING SCREW WAS ADDED INSTEAD. THE INSTRUMENT SET WAS THEREFORE HYGIENICALLY NOT OK AND COULD NOT BE USED FOR THE SURGERY. PATIENT RECEIVED UNNECESSARY ANESTHESIA. THE SURGERY WAS CANCELLED AND WILL BE MADE UP ON MONDAY (B)(6) 2022 UNDER STERILE HYGIENIC CONDITIONS." ADDITIONALLY, IT WAS REPORTED; THE PROCEDURE WAS EXTENDED HOWEVER THE LENGTH OF THE EXTENSION IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 15470888 ↗
• MalfunctionJun 11, 2021Component Missing; Component Missing

  THE FOLLOWING WAS REPORTED: AN ANKLE ARTHRODESIS WITH THE T2 SGA NAIL WAS TO TAKE PLACE. WHEN THE SALES REP ARRIVED, HE WAS INFORMED THAT THE LOANER INSTRUMENTS HAD NOT BEEN DELIVERED IN COMPLETE FORM. THE PATIENT WAS ALREADY ANESTHETIZED AND THE SURGERY HAD ALREADY BEGUN. THE SALES REP'S INTERNAL CLINIC INVESTIGATION REVEALED THAT TWO ESSENTIAL COMPONENTS (ITEM# 18063211 AND ITEM# 18063203) HAD NOT BEEN SUPPLIED. THE SALES REP WAS ASKED WHICH HOSPITAL NEARBY HAD THE SYSTEM PERMANENTLY INSTALLED. THE DEVICES WERE REQUESTED FROM THE NEARBY HOSPITAL. THEY WERE DELIVERED, AND THE SURGERY WAS COMPLETED. THERE WAS A 60-MINUTE SURGICAL DELAY DUE TO THIS ISSUE; AS A RESULT, THE ANESTHESIA HAD TO BE PROLONGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11982943 ↗