GLOBAL UNITE 2100-70-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295085942), received between Mar 1, 2019 and Sep 12, 2022 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (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 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.

• MalfunctionSep 12, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE TIP OF SCREWDRIVER IS ROUNDING OFF AND NOT FULLY ENGAGING SCREW. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15403466 ↗
• MalfunctionAug 22, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE TIP WAS ROUNDING AND WON'T ENGAGE SCREW PROPERLY. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15266122 ↗
• MalfunctionJul 20, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT TIP OF SCREWDRIVER DEFORMED DURING NORMAL USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15066267 ↗
• MalfunctionNov 24, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE END OF SCREW DRIVER DULLED DURING NORMAL USE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12868839 ↗
• MalfunctionNov 18, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE END OF THE SCREWDRIVER WAS ROUNDED OFF AND WOULD NOT FIT THE SCREWS PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12834666 ↗
• MalfunctionJun 16, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TIP OF SCREWDRIVER DEFORMED DURING NORMAL USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10158168 ↗
• MalfunctionJun 12, 2020Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE TIP OF SCREWDRIVER DEFORMED DURING NORMAL USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10149491 ↗
• MalfunctionJun 1, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE METAL TIP OF SCREWDRIVER WAS BENT AND NEEDS TO BE REPLACED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10106746 ↗
• MalfunctionMar 1, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE SCREWDRIVER TIP WAS BEGINNING TO STRIP OUT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8382863 ↗