ACUMED 3070-27015Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10806378126062), received between Feb 12, 2026 and Apr 1, 2026 — classified as 3 injuries.

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

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

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.

• 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 24758789 ↗
• 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 24758786 ↗
• InjuryFeb 12, 2026Material Fragmentation

  IT WAS REPORTED THAT THE SCREW BROKE IN THE DISTAL END OF THE SLOT IN THE WRIST SPANNING PLATE. IT SHEARED OFF RIGHT AT THE BONE SURFACE WITH ABOUT ONE THREAD LEFT UNDER THE HEAD OF THE SCREW. THE SURGEON MENTIONED IT WAS DENSE BONE AND HE LEFT THE BROKEN SCREW IN THE BONE AND MENTIONED THAT HE WOULD REMOVE IT USING A TREPHINE WHEN HE REMOVES THE WSP. HE MENTIONED THAT HE WASN'T TOO CONCERNED ABOUT THE REMOVAL BECAUSE THE BONE QUALITY WAS VERY GOOD AND THE PATIENT IS YOUNG. HE WAS ABLE TO INSERT A SECOND NL SCREW INTO THE PROXIMAL PORTION OF THE SAME SLOT, SO THE BREAKAGE DIDN'T AFFECT HIS FIXATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24328622 ↗