NA 395.133Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982200198), received between Apr 22, 2020 and Apr 22, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K033158, K961350, K971987); 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. How this data works · Data updated Oct 13, 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.

• MalfunctionApr 22, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING AN INSPECTION OF THE MINIFIXER SYSTEM, IT IS NOTED THAT THE HOLDING AND CONNECTING CLAMPS DO NOT FUNCTION APPROPRIATELY WITH THE OTHER DEVICES. NO PATIENT INVOLVEMENT. THIS IS REPORT 10 OF 10 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9986727 ↗
• MalfunctionApr 22, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING AN INSPECTION OF THE MINIFIXER SYSTEM, IT IS NOTED THAT THE HOLDING AND CONNECTING CLAMPS DO NOT FUNCTION APPROPRIATELY WITH THE OTHER DEVICES. NO PATIENT INVOLVEMENT. THIS IS REPORT 9 OF 10 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4) AND (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9986656 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033158, K961350, K971987. One submission often covers many models, so check the product and lot details in each record.

• Z-2451-2015 · Jul 29, 2015 · Terminated
  Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large) ; (S) intended to stabilize and provide treatment for fractures of the small bones, such as th