ACUMED 3070-27016Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10806378126079), received between Apr 1, 2026 and May 6, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 28, 2026Open, Classified

   Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.

   Z-2532-2026 · Root cause: Device Design · FDA record ↗

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.

• InjuryMay 6, 2026Material Fragmentation

  IT WAS REPORTED: 2 2.7MM NL SCREWS FROM AL NEXT BROKE DURING THE CASE. THE FIRST SCREW (16MM) BROKE WHILE THE SCREW WAS BEING USED TO PULL THE PLATE TO THE BONE. THE HEAD OF THE SCREW BROKE IN HALF AND THEN FELL THROUGH THE SLOT IN THE PLATE. THE SECOND SCREW HEAD SNAPPED OFF THE SCREW BEFORE IT WAS EVEN DOWN TO THE PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25104615 ↗
• InjuryApr 1, 2026Break

  IT WAS REPORTED: 3 OF THE 2.7MM NL SCREWS FROM THE ACULOC NEXT SET BROKE WHEN DRILLING IN THE PROXIMAL OBLONG FOR THE LONGER OF THE NEW NEXT WRIST SPANNING PLATES. PATIENT WAS 40-YEAR-OLD MALE. GOOD DIAPHYSEAL BONE. WE ARE WONDERING IF THERE NEEDS TO BE A DIFFERENT LARGER DRILL OR A TAP AVAILABLE FOR DIAPHYSEAL BONE. THE SCREWS DID NOT BREAK RIGHT BELOW THE SCREW HEAD; IT WAS A FEW THREADS DOWN. BASICALLY, WHENEVER THE BONE STARTED GIVING SOME RESISTANCE THEY SNAPPED, BUT IT WAS FELLOW WITH THE SURGEON AND HE WAS VERY CONTROLLED AND WASN'T OVER TORQUING. SCREWS SHOULD NOT HAVE BEHAVED LIKE THAT EVEN WITH SOME RESISTANCE. IT WAS VERY ODD. WE LEFT TWO IN THE OBLONG WITH THE HEADS SHEARED OFF AND A THIRD IN A SCREW HOLE DISTAL I BELIEVE. WE HAD TWO SCREWS PROXIMAL THAT WE LOCKED AROUND THOSE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24758788 ↗