NA 02.226.750Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982060303), received between Dec 28, 2017 and Dec 28, 2017 — 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 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.

• InjuryDec 28, 2017Break; Break

  THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER (B)(4)., A COPY IS ATTACHED. THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. IT WAS REPORTED THAT A PATIENT HAD OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE LEFT 5TH METATARSAL ON (B)(6) 2017. THE FIRST 4.5 MM SCREW THAT WAS IMPLANTED BROKE INTO TWO PIECES INSIDE THE METATARSAL. THE PHYSICIAN RETRIEVED HALF OF THE SCREW WITHOUT ANY DIFFICULTY AND THE OTHER HALF WAS RETAINED INSIDE THE METATARSAL. AN ADDITIONAL 6.5 MM SCREW WAS PLACED THROUGH THE FRACTURE SITE TO GAIN REDUCTION. THE PATIENT WAS DISCHARGED HOME WITH FOLLOW UP PLANNED IN 2-3 WEEKS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO REPORTED SURGICAL DELAY. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED TO COMPLETE THE PROCEDURE. NO UNANTICIPATED X-RAYS WERE TAKEN. CONCOMITANT PARTS : UNKNOWN SCREWDRIVER (UNKNOWN PART AND LOT NUMBER, UNKNOWN QUANTITY). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7151489 ↗