LCP 03.113.015Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982072825), received between Sep 20, 2022 and Nov 10, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

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

• InjuryNov 10, 2025Break; Break

  IT WAS REPORTED THAT THE PUSH PULL REDUCTION TOOL WAS USED DURING PROXIMAL HUMERAL PLATING AS PER RECOMMENDED TECHNIQUE. THE TIP OF INSTRUMENT BROKE INSIDE THE PATIENTS BONE. THIS BROKEN ITEM WAS REMOVED BY A SECONDARY INCISION. THERE WAS A 10 MINUTES OF SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: Insufficient Information

  MAUDE report 23513619 ↗
• MalfunctionSep 20, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE NETHERLANDS AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE COMPRESSION STICK BROKE DURING A PROCEDURE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. THIS REPORT INVOLVES ONE PULL REDUCTION DEVICE F/3.5MM LCP PERCUTANEOUS INSTR SYS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15455097 ↗