NA 04.211.060Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982119223), received between Apr 28, 2023 and Apr 28, 2023 — 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.

• InjuryApr 28, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, AFTER SURGERY, 3 SCREWS FOR VA-DHP WERE FOUND TO BE BROKEN. ON (B)(6) 2023, THE PATIENT UNDERWENT AN ORIF SURGERY FOR HUMERUS SUPRACONDYLAR COMMINUTED FRACTURE AND OLECRANON FRACTURE. THE PREOPERATIVE PLAN WAS TO USE A DOUBLE PLATE AT THE HUMERUS, BUT JUDGING FROM THE CONDITION OF THE FRACTURE, A VA-DHP AND OLECRANON PLATE WERE USED. THE VA-DHP WAS USED ONLY AT THE MEDIAL SIDE OF THE HUMERUS. AFTER THE SURGERY THREE SCREWS WERE FOUND BROKEN. SINCE THE PATIENT HAD BEEN IN POSTOPERATIVE SPLINT FIXATION AND HAD BEEN INSTRUCTED TO PERFORM REHABILITATION ONLY DISTAL TO THE WRIST, THERE WAS NO PARTICULAR STRESS ON THE FRACTURE SITE. ALTHOUGH IT IS POSSIBLE THAT THE PATIENT MAY HAVE BEEN MAKING TURNING MOVEMENTS, ETC. WHILE SLEEPING, THE SURGEON SUSPECTS THE INSUFFICIENT STRENGTH OF THE SCREWS BECAUSE THE BREAKAGE OCCURRED APPROXIMATELY 1 WEEK AFTER SURGERY. ON (B)(6) 2023, A REOPERATION WILL BE PERFORMED. IN THE REOPERATION, ONLY THE MOST DISTAL SCREW WILL BE LEFT, AND THE REMAINING SCREWS AND PLATE WILL BE REMOVED, AND K-WIRES WILL BE USED FOR THE TREATMENT. THIS REPORT INVOLVES ONE

  Patient problems: Failure of Implant

  MAUDE report 16833369 ↗