ACUMED 80-4155Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10806378121661), received between Jan 6, 2026 and May 29, 2026 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING A REMOVAL CASE, THE PATIENT NEEDED A SCAPHOID SCREW REMOVED AND THE DRIVER TIP BROKE TRYING TO REMOVE THE SCREW. THE PROCEDURE WAS COMPLETED AFTER A 30 MIN DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25337518 ↗
• MalfunctionMay 29, 2026Material Fragmentation

  IT WAS REPORTED THAT THE DRIVER BROKE IMPLANTING THE SCREW. THE SALES REPRESENTATIVE REPORTED THE SURGICAL TECHNIQUE WAS FOLLOWED, UTILIZED DENSE BONE LONG DRILL AND THE PROCEDURE WAS COMPLETED USING ANOTHER DRIVER AFTER A 15 MIN DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25337516 ↗
• InjuryMay 21, 2026Material Fragmentation

  IT WAS REPORTED: DURING A MID CORPOL FUSION - DRIVE TIP BROKE TWICE INSERTING SCREW INTO CAPITOLE. HAD TO INCISE DOWN - REMOVE SCREW WITH PLIERS.

  Patient problems: Insufficient Information

  MAUDE report 25249878 ↗
• InjuryMay 21, 2026Material Fragmentation

  IT WAS REPORTED: DURING A MID CORPOL FUSION - DRIVE TIP BROKE TWICE INSERTING SCREW INTO CAPITOLE. HAD TO INCISE DOWN - REMOVE SCREW WITH PLIERS.

  Patient problems: Insufficient Information

  MAUDE report 25249877 ↗
• MalfunctionMay 15, 2026Material Fragmentation

  THE ACUMED SALES REPRESENTATIVE REPORTED, "THE DOCTOR WAS FIXING A SCAPHOID FRACTURE, BROKE 2 DRIVER TIPS 3/4 OF THE WAY DOWN. THE PROCEDURE WAS COMPLETED USING AN EASY OUT. THERE WAS A 60 MINUTE DELAY DUE TO THE MALFUNCTIONS AND THE PATIENT REMAINED STABLE."

  Patient problems: Insufficient Information

  MAUDE report 25194261 ↗
• MalfunctionMay 15, 2026Material Fragmentation

  THE ACUMED SALES REPRESENTATIVE REPORTED, "THE DOCTOR WAS FIXING A SCAPHOID FRACTURE, BROKE 2 DRIVER TIPS 3/4 OF THE WAY DOWN. THE PROCEDURE WAS COMPLETED USING AN EASY OUT. THERE WAS A 60 MINUTE DELAY DUE TO THE MALFUNCTIONS AND THE PATIENT REMAINED STABLE."

  Patient problems: Insufficient Information

  MAUDE report 25194260 ↗
• MalfunctionMay 15, 2026Material Fragmentation

  THE ACUMED SALES REPRESENTATIVE REPORTED, "THE DOCTOR DID A SCAPHOID, BROKE 2 DRIVER TIPS, BROKE AND SHATTERED THE TIP ABOUT HALF WAY DOWN. THE PROCEDURE WAS COMPLETED BY FISHING PIECES OUT, EASY OUT, SCREW LEFT SLIGHTLY PROMINENT. THERE WAS A 45 MINUTE DELAY DUE TO THE MALFUNCTIONS AND THE PATIENT REMAINED STABLE."

  Patient problems: Foreign Body In Patient

  MAUDE report 25194182 ↗
• MalfunctionMay 15, 2026Material Fragmentation

  THE ACUMED SALES REPRESENTATIVE REPORTED, "THE DOCTOR DID A SCAPHOID, BROKE 2 DRIVER TIPS, BROKE AND SHATTERED THE TIP ABOUT HALF WAY DOWN. THE PROCEDURE WAS COMPLETED BY FISHING PIECES OUT, EASY OUT, SCREW LEFT SLIGHTLY PROMINENT. THERE WAS A 45 MINUTE DELAY DUE TO THE MALFUNCTIONS AND THE PATIENT REMAINED STABLE."

  Patient problems: Foreign Body In Patient

  MAUDE report 25194180 ↗
• MalfunctionJan 6, 2026Material Fragmentation

  IT WAS REPORTED THAT THE STICK FIT DRIVER SNAPPED AND BROKE OFF WHILE INSERTING ATR3 MINI SCREW, THERE WAS NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23985510 ↗