NA 404.032Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982207036), received between Dec 13, 2017 and Dec 13, 2017 — classified as 1 malfunction.

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

• MalfunctionDec 13, 2017Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A PROXIMAL HUMERUS OSTEOSYNTHESIS PROCEDURE, THE DOCTOR PLACED A SCREW IN THE VERY ANGLED DISTAL FRAGMENT AND DURING THE FINAL ADJUSTMENT WITH THE SCREWDRIVER, THE SCREW BROKE. A PIECE OF THE SCREW REMAINED IN THE PATIENT¿S BONE. REPORTEDLY THERE WAS NO SURGICAL DELAY. CONCOMITANT DEVICE: SCREWDRIVER (PART/LOT UNKNOWN, QUANTITY 1). (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7113395 ↗