NA 394.181Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982199621), received between Jun 23, 2022 and Jun 23, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 THE SMALL TROCAR OF OUR LARGE EXTERNAL FIXATOR SET WAS BENT OUTSIDE OF SURGERY DURING THE CARE OF SPD. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE(1) DEVICE 3.5MM TROCAR-SHORT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14786342 ↗