EXPert 03.010.507Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982069238), received between Nov 21, 2024 and Dec 9, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K033618); they may or may not involve this specific model.

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.

• MalfunctionDec 9, 2024Material Deformation; Material Deformation

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE WIRE BENT IN MULTI GUIDE FROM PRESSURE SO WIRE DOESN¿T SLIDE SMOOTHLY ANYMORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20883521 ↗
• MalfunctionNov 21, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE GUIDE BROKE DURING PRE-OPERATIVE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20747433 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033618. One submission often covers many models, so check the product and lot details in each record.

• Z-2058-2013 · Nov 2, 2012 · Terminated
  Synthes Trauma Nail System. The devices are indication for bone fixation.