NA 323.054Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982190710), received between Sep 23, 2024 and Apr 21, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE 2025, DURING A SURGERY, FIVE PROXIMAL HUMERUS SLEEVES WERE USED. THE DRILL BIT WAS USED THROUGH FIVE SLEEVES AND SEEMED TO BEND OR WARP THE SLEEVES. THE POWER SHAFT NEEDED TO BE REMOVED THROUGH THE SLEEVE. FIVE WERE USED. THE DEPTH GAUGE WAS ALSO USED AND THE HOOK WAS SUPER BENT ON TWO OF THE DEPTH GAUGES. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873274 ↗
• MalfunctionApr 21, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A PROXIMAL, FIVE PROXIMAL HUMERUS SLEEVES WERE USED. THE DRILL BIT WAS USED THROUGH FIVE SLEEVES AND SEEMED TO BEND OR WARP THE SLEEVES. THE POWER SHAFT NEEDS TO BE REMOVED THROUGH THE SLEEVE. FIVE WERE USED. THE DEPTH GAUGE WAS ALSO USED AND THE HOOK WAS SUPER BENT ON TWO OF THE DEPTH GAUGES. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21871914 ↗
• MalfunctionApr 21, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A PROXIMAL, FIVE PROXIMAL HUMERUS SLEEVES WERE USED. THE DRILL BIT WAS USED THROUGH FIVE SLEEVES AND SEEMED TO BEND OR WARP THE SLEEVES. THE POWER SHAFT NEEDS TO BE REMOVED THROUGH THE SLEEVE. FIVE WERE USED. THE DEPTH GAUGE WAS ALSO USED AND THE HOOK WAS SUPER BENT ON TWO OF THE DEPTH GAUGES. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21871912 ↗
• MalfunctionApr 21, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A PROXIMAL, FIVE PROXIMAL HUMERUS SLEEVES WERE USED. THE DRILL BIT WAS USED THROUGH FIVE SLEEVES AND SEEMED TO BEND OR WARP THE SLEEVES. THE POWER SHAFT NEEDS TO BE REMOVED THROUGH THE SLEEVE. FIVE WERE USED. THE DEPTH GAUGE WAS ALSO USED AND THE HOOK WAS SUPER BENT ON TWO OF THE DEPTH GAUGES. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21871911 ↗
• MalfunctionApr 21, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A PROXIMAL, FIVE PROXIMAL HUMERUS SLEEVES WERE USED. THE DRILL BIT WAS USED THROUGH FIVE SLEEVES AND SEEMED TO BEND OR WARP THE SLEEVES. THE POWER SHAFT NEEDS TO BE REMOVED THROUGH THE SLEEVE. FIVE WERE USED. THE DEPTH GAUGE WAS ALSO USED AND THE HOOK WAS SUPER BENT ON TWO OF THE DEPTH GAUGES. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21871910 ↗
• MalfunctionSep 26, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, DURING A CEMENTATION OF A HUMERUS, A PROXIMAL HUMERUS PLATE WAS USED. THE DRILL SLEEVES USED WERE STUCK DUE TO CEMENT ON THE DRILL BIT OR COLD WELDED ON THE SLEEVES. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20311248 ↗
• MalfunctionSep 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A CEMENTATION OF A HUMERUS, A PROXIMAL HUMERUS PLATE WAS USED. THE DRILL SLEEVES USED WERE STUCK DUE TO CEMENT ON THE DRILL BIT OR COLD WELDED ON THE SLEEVES. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20300941 ↗
• MalfunctionSep 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A CEMENTATION OF A HUMERUS, A PROXIMAL HUMERUS PLATE WAS USED. THE DRILL SLEEVES USED WERE STUCK DUE TO CEMENT ON THE DRILL BIT OR COLD WELDED ON THE SLEEVES. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20300911 ↗
• MalfunctionSep 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A CEMENTATION OF A HUMERUS, A PROXIMAL HUMERUS PLATE WAS USED. THE DRILL SLEEVES USED WERE STUCK DUE TO CEMENT ON THE DRILL BIT OR COLD WELDED ON THE SLEEVES. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20300751 ↗
• MalfunctionSep 23, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A CEMENTATION OF A HUMERUS ON AN UNKNOWN DATE IN 2024, A PROXIMAL HUMERUS PLATE WAS USED. THE DRILL SLEEVES USED WERE STUCK DUE TO CEMENT ON THE DRILL BIT OR COLD WELDED ON THE SLEEVES. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR A 2.8MM DRILL SLEEVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20281156 ↗