LAG SCREW SHEATH 0617-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848665010756), received between Apr 24, 2024 and Jan 28, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Connection 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionJan 28, 2025Positioning Failure; Positioning Failure

  ON 01/02/2025 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN 0617-300 LAG SCREW SHEATH WITH HANDLE WIRE SHEATH DID NOT ENGAGE WITH LAG SCREW DRILL/SCREW SHEATH. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21253821 ↗
• MalfunctionApr 24, 2024Connection Problem; Connection Problem

  IT WAS REPORTED DURING A FEMUR REPAIR THE SPRING GUIDE FAILED AND THE ASSEMBLY WAS REMOVED. THE PIN WAS ALREADY SET WHEN THE FAILURE OCCURRED. THE CASE COMPLETED WITH NO FURTHER ISSUES. THE PATIENT IS FINE TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19173076 ↗