LCS 99-2011Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295253778), received between Apr 8, 2019 and Nov 30, 2021 — classified as 2 malfunctions.

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

• MalfunctionNov 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

  THIS IS A T-HANDLE FROM THE SIGMA SP2 SET THAT HAS STOPPED GRIPPING/HOLDING THE INTRAMEDULLARY ROD. THIS WAS DISCOVERED UPON SETTING UP FOR A CASE AND THE RESOLUTION WAS TO OPEN ANOTHER INSTRUMENT TRAY¿ THE OPERATION WAS NOT DELAYED AND THE PATIENT CAME TO NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12892734 ↗
• MalfunctionApr 8, 2019Break; Break

  IT WAS REPORTED T-HANDLE BROKE DURING SURGERY. THE PUSH BUTTON RELEASE ON THE SIDE BROKE OFF INTO TWO PARTS, BOTH WERE RETRIEVED AND IT WAS DISCARDED BY OPERATING ROOM NO SURGICAL DELAY HAPPEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8491034 ↗