NA 1806-0093SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540195975), received between May 21, 2018 and May 20, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionMay 20, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT "MANAGEMENT OF A FRACTURE OF THE LEFT HUMERUS, PLACEMENT OF THE STRYKER REDUCTION GUIDE. ATTEMPT TO INSERT A RIGID STRYKER NAIL. THE SURGICAL TEAM NOTICED AN UNUSUAL AND UNEXPECTED DEFORMATION OF THE NAILING GUIDE, WHICH CAUSED THE NAIL TO JAM. AS A RESULT, THE SURGEON CHANGED THE METHOD AND PERFORMED AN ELASTIC NAILING OSTEOSYNTHESIS OF THE METAIZEAU TYPE". ADDITIONALLY THERE WAS A 45 MINUTE DELAY TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14461706 ↗
• MalfunctionMay 21, 2018Device Contamination with Chemical or Other Material; Packaging Problem; Packaging Problem

  IN IN-COMING INSPECTION AT DISTRIBUTION, IT WAS FOUND THAT THERE WAS A FOREIGN MATERIAL (HAIR) IN BLISTER. NO PATIENT INVOLVEMENT, ADVERSE CONSEQUENCES, DELAY OR MEDICAL INTERVENTION.

  Patient problems: No Patient Involvement

  MAUDE report 7531076 ↗