NA 389.814Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034776804), received between Jan 13, 2020 and Jun 1, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (1 report).

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. How this data works · Data updated Oct 13, 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.

• MalfunctionJun 1, 2021Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT THE DEVICE WAS RECEIVED DAMAGED AT THE LOCAL DC. THE DEVICE WAS UNABLE TO ATTACH TO THE SCREWDRIVER SHAFT, AND COULDN¿T HOLD THE SCREW. THIS REPORT IS FOR A HOLDING SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11917397 ↗
• MalfunctionJan 13, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PRIOR TO A CASE ON AN UNKNOWN DATE, THE SCRUB NURSE WAS TRYING TO ASSEMBLE THE ANTERIOR TENSION BAND (ATB) DRIVER. THE INNER SHAFT WAS STUCK INSIDE THE SELF-RETAINING SLEEVE. A SIMILAR PRODUCT WAS USED INSTEAD. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A HOLDING SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9582908 ↗