NA 2351-3340SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327361872), received between Jun 20, 2019 and Jun 20, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Advance” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2019Failure to Advance

  IT WAS REPORTED THAT, WHILE USING THE T2 ALPHA PF NAIL, THE SURGEON PUT THE NAIL DOWN THE CANAL AND WAS USING THE RECON LOCKING CONSTRUCT AND WENT TO PUT THE INFERIOR WIRE IN USING THE THREADED RECON WIRE AND TRIED TO ADJUST THE TRAJECTORY ANTERIOR AND THE WIRE CONTINUOUSLY MISSED THE NAIL ANTERIOR. BECAUSE THE WIRE WOULD NOT GO THROUGH THE NAIL, THE DOCTOR WAS FORCED TO USE A DIFFERENT LOCKING CONFIGURATION WHICH DELAYED THE CASE. SURGICAL DELAY OF 30 MINUTES WITHOUT ADDITIONAL ANESTHESIA TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8716502 ↗