NA 311.43.99Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034768717), received between Apr 22, 2020 and Apr 22, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionApr 22, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SMALL HANDLE WITH QUICK COUPLING BROKE DURING FIXING THE RADIUS FRACTURE TO THE PATIENT. WHEN THE SURGEON WAS PUTTING THE FINAL LAG SCREW IN, HE APPLIED A LOT OF FORCE ON IT AND THE HANDLE CRUMBLED AND BROKE INSIDE OF HIS HAND. SEVERAL PIECES LIKE 5 OR 6 WERE ALL RETRIEVED TO THE PATIENT. ALL OF THE FRAGMENTS OF THE HANDLE WERE REMOVED FROM THE PATIENT AND IT ONLY CAUSED A ONE (1) MINUTE SURGICAL DELAY AND PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS: LAG (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR 1 HANDLE WITH QUICK COUPLING, SMALL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9986146 ↗