NA 314.48Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10887587037448), received between Oct 30, 2018 and Jul 1, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET AT (B)(4) SITE, IT WAS DISCOVERED THAT THE SCREWDRIVER BLADE WITH HOLDING SLEEVE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8750474 ↗
• MalfunctionJun 28, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INSPECTION OF A LOANER SET IT WAS OBSERVED THAT THE SCREWDRIVER SHAFT WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. DURING PRELIMINARY INVESTIGATION OF THE RETURNED DEVICE IT WAS OBSERVED THE DEVICE FELL APART AND IS MISSING COMPONENTS. THIS REPORT IS FOR ONE (1) 1.0MM SCREWDRIVER BLADE WITH HOLDING SLEEVE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8746364 ↗
• MalfunctionOct 30, 2018Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN UNKNOWN HAND SURGERY ON (B)(6) 2018, THE SCREWDRIVER BLADE WITH HOLDING SLEEVE WAS FOUND TO HAVE AN ISSUE. IT WAS ALSO NOTICED THAT THE 2 HANDLES WITH MINI QUICK COUPLING WERE STUCK TOGETHER WITH THE CRUCIFORM SCREWDRIVER BLADES. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY AND IF SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. DURING THE SAME PROCEDURE IT WAS ALSO NOTED THAT THE TWO (2) OF THE SCREWDRIVERS ALSO HAVE WORN TIPS AND WEAR AND TEAR. THIS REPORT IS FOR ONE (1) 1.0MM SCREWDRIVER BLADE WITH HOLDING SLEEVE. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8021935 ↗
• MalfunctionOct 30, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN UNKNOWN HAND SURGERY ON (B)(6) 2018, THE SCREWDRIVER BLADE WITH HOLDING SLEEVE WAS FOUND TO HAVE AN ISSUE. IT WAS ALSO NOTICED THAT THE 2 HANDLES WITH MINI QUICK COUPLING WERE STUCK TOGETHER WITH THE CRUCIFORM SCREWDRIVER BLADES. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY AND IF SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. DURING THE SAME PROCEDURE IT WAS ALSO NOTED THAT THE TWO (2) OF THE SCREWDRIVERS ALSO HAVE WORN TIPS AND WEAR AND TEAR. THIS REPORT IS FOR ONE (1) 1.0MM SCREWDRIVER BLADE WITH HOLDING SLEEVE. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8021915 ↗