NA 03.010.489Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982069078), received between Jun 10, 2022 and Feb 6, 2023 — classified as 2 malfunctions.

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

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.

• MalfunctionFeb 6, 2023Break; Break

  IT WAS REPORTED THAT ON JANUARY 16, 2023, THE SLEEVE LOCK WAS DISCOVERED BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) AIMING ARM FOR RETRO SPIRAL BLADE LCKNG. THIS IS REPORT 1 OF 1 FOR COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16308963 ↗
• MalfunctionJun 10, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, BOTH PLASTIC LOCKING TABS WERE BROKEN IN TRANSIT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) AIMING ARM FOR RETROGRADE SPIRAL BLADE LOCKING THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14651901 ↗

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.