NA 04.226.680SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982123718), received between Aug 1, 2022 and Aug 1, 2022 — 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.

• MalfunctionAug 1, 2022Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING ORIF SURGERY FOR TRANSVERSE FRACTURE OF SHAFT OF CLAVICLE, THE SCREW IN QUESTION WAS PLANNED TO BE INSERTED INTO THE MEDULLARY CAVITY. THE SURGEON DRILLED ONLY THE PROXIMAL CORTEX TO INSERT THE SCREW AND STARTED INSERTION. SINCE THE PATIENT WAS YOUNG, THE MEDULLARY CAVITY WAS NARROW, AND A GUIDE WIRE WAS INSERTED SLIGHTLY FLEXED. THE BONE FELT HARD WHEN THE SCREW WAS INSERTED, BUT THE SURGEON KEPT INSERTING WITH FORCE, AND WHEN THE IMAGE INTENSIFIER WAS CHECKED AFTER THE SCREW WAS INSERTED TO SOME EXTENT, THE SCREW WAS FOUND TO BE BROKEN IN THE AREA BETWEEN THE THREADED PART AND THE SHAFT. THE SURGEON INSERTED ADDITIONAL GUIDE WIRE THROUGH THE SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 4.5MM TI HEADLESS COMPRESSION SCR/SHORT THRD/80MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15138369 ↗