NA 310.29Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982186430), received between Sep 12, 2018 and Dec 15, 2022 — 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. 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.

• MalfunctionDec 15, 2022Break; Break

  THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15986917 ↗
• MalfunctionSep 12, 2018Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, THE SURGEON HAD DIFFICULTY WHEN DRILLING WITH THE 3.2 DRILL BITS FROM THE LOCKING COMPRESSION PLATE (LCP) BOX OF LARGE FRAGMENTS (TITANIUM). IT IS UNKNOWN HOW MANY DEVICES WERE AFFECTED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7869967 ↗