NA 214.772Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982154538), received between Jun 9, 2021 and Jul 28, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2021Break; Break

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS INVOLVING A TOTAL OF 1 ACTUAL DEVICES FOR BROKEN SCREWS. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12242580 ↗
• MalfunctionJun 9, 2021Break

  PLACING A SYNTHES 4.5 CANN SCREW FULLY THREADED 72 MM REF 214.772 INTO PATIENTS LEFT FOOT. WHEN TAKEN, X-RAY AFTER PLACEMENT OF SCREW DOCTOR NOTED THE HEAD OF THE SCREW APPEARED TO HAVE BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 11965044 ↗