Tools - Screws HXDRIVR-2.5 AORecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842188112621), received between Dec 11, 2017 and Dec 11, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Residue After Decontamination” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2017Residue After Decontamination; Residue After Decontamination

  ON (B)(6) 2017 IT WAS REPORTED TO A TRIMED CUSTOMER SERVICE REPRESENTATIVE, THAT FOUR 2.5 AO HEX DRIVER'S EPOXY HAD BLED AFTER STERILIZING THE TRAY. THIS IS THE THIRD OCCURENCE OF THIS TYPE OF COMPLAINT THIS YEAR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7105708 ↗
• MalfunctionDec 11, 2017Residue After Decontamination; Residue After Decontamination

  A HXDRIVR-2.5 AO AND HXDRIVR-3.5 AO WERE FLASHED IN AN AUTOCLAVE IN CENTRAL STERILE DUE TO A HOLE IN THE STERILE WRAPPING. THE SCRUB TECH NOTICED UPON OPENING THE TRAY FOR POST-STERILIZATION INSPECTION, THAT BOTH DRIVERS HAD EPOXY COMING OFF AFTER STERILIZATION. THE TRAY WAS A LOANER TRAY, THE SURGEON STATED THAT THIS INCIDENT WAS NOT AN ISSUE FOR THEM AS THE DRIVERS WERE NOT USED IN SURGERY AND THEY FELT THAT THIS INCIDENT DID NOT NEGATIVELY AFFECT THE PATIENT'S HEALTH OR DELAY SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7105706 ↗