NA 390.037Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982198051), received between Sep 25, 2024 and Sep 30, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K040258, K090658, K161417); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON SEPTEMBER 23, 2024 THE CLAMPS WOULD NOT TIGHTEN. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO OPERATION INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20334055 ↗
• MalfunctionSep 30, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024 THE CLAMPS WOULD NOT TIGHTEN. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO OPERATION INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20334023 ↗
• MalfunctionSep 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6), 2024 THE CLAMPS WON'T TIGHTEN. THERE WAS NO PATIENT INVOLVEMENT. NO OPERATION INVOLVED. THERE WAS NO OTHER INFORMATION PROVIDED. THIS REPORT INVOLVES ONE 8.0MM/11.0MM COMBINATION CLAMP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20301545 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040258, K090658, K161417. One submission often covers many models, so check the product and lot details in each record.

• Z-1833-2014 · Apr 10, 2014 · Terminated
  Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.