NA 03.226.000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982077004), received between Mar 31, 2020 and Mar 31, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (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 18, 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.

• InjuryMar 31, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A SURGERY WITH HEADLESS COMPRESSION SCREWS. DURING THE SURGERY, THE SURGEON FOUND THAT THE INSTRUMENT SET DELIVERED TO THE HOSPITAL CONTAINED THE COMPRESSION SLEEVE FOR 3.0 MM (03.226.000) INSTEAD OF THE COMPRESSION SLEEVE FOR 2.4 MM (03.226.016). THE SURGEON HAD NO CHOICE BUT TO INSERT 3.0 MM HEADLESS COMPRESSION SCREWS. HE HAS CONCERN FOR SECONDARY FRACTURE BECAUSE THE CORTICAL BONE BECAME THINNER DUE TO THE INSERTED SCREW SIZE WHICH IS LONGER THAN PLANNED ONE. THERE WAS NO REPORTED DELAY. THE PATIENT OUTCOME WAS STABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Injury

  MAUDE report 9907781 ↗