NA 03.641.010Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034720180), received between Oct 15, 2021 and Oct 15, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Compatibility Problem” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionOct 15, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE SURGERY WITH THE TFNA LONG NAIL. DURING THE SURGERY, WHEN THE SURGEON TRIED TO INSERT THE DISTAL STOP BY USING THE SURELOCK IN QUESTION, THE DRILL INTERFERED WITH BOTH HOLES OF THE NAIL, SO THE REAMING ENDED UP WITH 1.5 MM OVERREAMING. AFTER INSERTING THE NAIL, THE SURGEON ADJUSTED THE FRONT AND BACK OF THE SURELOCK BY USING THE IMAGE. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICES REPORTED: UNKNOWN TFNA - NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). UNKNOWN GUIDES/SLEEVES/AIMING: SLEEVE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) SURE-LOCK. THIS REPORT IS 1 OF 1 OF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12639102 ↗