APTUS A-5750.14/1SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630037882060), received between Apr 1, 2026 and Apr 1, 2026 — 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 1, 2026Break; Insufficient Device Problem Information

  AT (B)(6) HOSPITAL IN (B)(6), A SURGEON PERFORMING WRIST SURGERY UTILIZED A 2.5 TRILOCK ULNA SHORTENING PLATE IN COMBINATION WITH A 2.5 TRILOCK SCREW. DURING INSERTION OF THE 2.5 TRILOCK SCREW INTO THE SECOND DISTAL HOLE OF THE PLATE AND SUBSEQUENT LOCKING WITH A DRIVER, THE SCREW HEAD SEPARATED. THE BROKEN SCREW REMAINED IN SITU, AND THIS INCIDENT WILL BE REPORTED TO THE PMDA. INTRAOPERATIVELY, THE SURGEON ASSESSED THAT REMOVAL OF THE BROKEN SCREW DURING THE SAME PROCEDURE WOULD BE CHALLENGING. CONSEQUENTLY, THE DECISION WAS MADE TO LEAVE THE FRAGMENT IN PLACE, WITH PLANS TO EMPLOY A RESCUE KIT OR A COMPARABLE SOLUTION FOR EXTRACTION AT THE TIME OF SCREW REMOVAL. THE SURGEON REPORTED THAT THE PATIENT'S BONE QUALITY WAS HARD. THE SCREW WAS PRE-DRILLED WITH A SUITABLE TWIST DRILL, AND BASED ON THE AVAILABLE INFORMATION, EXCESSIVE FORCE WAS NOT APPLIED DURING INSERTION. NO ADDITIONAL X-RAYS ARE AVAILABLE FOR ANALYSIS. DESPITE THIS INTRAOPERATIVE COMPLICATION, THE SURGEON CONFIRMED THAT THE INTENDED SURGICAL OUTCOME WAS ACHIEVED.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 24757002 ↗