LCP 03.113.013Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982072801), received between Feb 22, 2021 and Feb 22, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

• MalfunctionFeb 22, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION SURGERY FOR THE PROXIMAL HUMERAL FRACTURE. BEFORE THE SURGERY, WHEN THE HOSPITAL CHECKED THE DEVICES, A DRILL BIT COULDNT BE INSERTED INTO THE DRILL SLEEVE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) COMPRESSION DRILL GUIDE F/3.5 MM LCP PERCUTANEOUS INSTR SYS. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11359252 ↗