NA 04.211.054Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982119193), received between Apr 28, 2023 and Jun 12, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2025Break; Break

  IT WAS REPORTED THE SURGEON NOTED THAT SOME METAL MATERIAL SHAVINGS CAME OUT WHEN HE INSERTED THE SCREWS INTRAOPERATIVELY. SURGERY DATE IS UNKNOWN. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY OR HOW THE PROCEDURE WAS COMPLETED. NO KNOWN PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22194139 ↗
• MalfunctionOct 31, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT THE ORIF WITH THE VA LOCKING SCREW IN QUESTION FOR THE COMMISSURAL HUMERUS FRACTURE. THE FRACTURE WAS TEMPORARILY FIXED WITH K-WIRE AND FOUR HOLES OF VA-DHP POSTERIOR LATERAL WERE TEMPORARILY FIXED BOTH PROXIMALLY AND DISTALLY. FIRST, THE SCREW IN QUESTION WAS INSERTED. AFTER INSERTION, IT WAS CONFIRMED THAT THE SCREW BROKE JUST BELOW THE SCREW HEAD WHEN THE SURGEON ATTEMPTED TO CHECK THE LATERAL IMAGE. THE BROKEN SCREW WAS REMOVED. A CORTEX SCREW WAS INSERTED INTO THE THIRD HOLE FROM THE PROXIMAL. THEN, THE DISTAL TO PROXIMAL AREA WERE FIXED, AND INNER AREA WAS FIXED WITH A PLATE. THE PATIENT WAS IN A POSTERIOR APPROACH AND THE IMAGE WAS PLACED AT AN ANGLE. THE ONLY WAY TO CHECK THE LATERAL IMAGE WAS TO TWIST THE AFFECTED SIDE, WHICH APPLIED AN EXCESSIVE LOAD ON THE SCREW IN QUESTION. THE SURGEON GUESSED THAT IT CAUSED THE SCREW BREAKAGE. IN ADDITION, THE PATIENT REMAINED UNSTABLE EVENT AFTER THE REDUCTION AND TEMPORARY FIXATION, WHICH MIGHT HAVE CAUSED ONLY THE DISTAL FRAGMENT TO TWIST WHEN THE ARM WAS TWISTED. THIS WAS THE FIRST TIME THE SURGEON HAS EXPERIE

  Patient problems: Insufficient Information

  MAUDE report 18039484 ↗
• 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 ON

  Patient problems: Failure of Implant

  MAUDE report 16832214 ↗