NA 02.226.770Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982060440), received between Apr 3, 2018 and Apr 3, 2018 — classified as 1 injury.

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.

• InjuryApr 3, 2018Break; Break

  IT WAS REPORTED THAT DURING A LEFT DISTAL FIBULA FRACTURE REPAIR ON (B)(6) 2018, A 4.5MM HEADLESS COMPRESSION SCREW BROKE UPON INSERTION. THE SCREW BROKE INTO TWO PIECES, HALF OF THE SCREW REMAINED IN THE PATIENT AND THE OTHER HALF IS RETAINED AT THE HOSPITAL. THE SCREWDRIVER THAT WAS USED WITH THE SCREW DID NOT EXPERIENCE ANY MALFUNCTIONS. THERE WAS AN APPROXIMATE TEN MINUTE DELAY DUE TO THE SCREW BREAKING. THE SURGERY COULD NOT BE COMPLETED SUCCESSFULLY AND THE PATIENT WAS CLOSED UP AND SURGERY WILL BE RESCHEDULED WHEN THE SKIN HEALS. THE PATIENT WAS INVOLVED IN A LEG CRUSHING INJURY. UPON COMPLETION OF STABILIZING THE PATIENT'S LEG THE OUTCOME OF PATIENT WAS STABLE. NO X-RAYS ARE AVAILABLE. CONCOMITANT DEVICE REPORTED: SCREWDRIVER (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 4.5MM HEADLESS COMPRESSION SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7391668 ↗