NA 314.67.97Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982189004), received between May 9, 2019 and Oct 23, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2024Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE THE HOLDING SLEEVE HAS A BROKEN PRONG AND ISN'T ABLE TO FUNCTION PROPERLY. IT IS UNKNOWN WHEN THE ISSUE WAS OBSERVED. IT IS UNKNOWN IF THERE IS PATIENT INVOLVEMENT. IT IS UNKNOWN IF REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION OCCURRED. PART IS NON REPAIRABLE.

  Patient problems: Insufficient Information

  MAUDE report 20515627 ↗
• MalfunctionSep 30, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024 , A HOLDING SLEEVE WAS BROKEN. THERE WAS NO OPERATION INVOLVED; NO PATIENT INVOLVED. THIS REPORT IS FOR A CRUCIFORM SCREWDRIVER SHAFT WITH HOLDING SLEEVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20334558 ↗
• MalfunctionJun 22, 2021Device-Device Incompatibility; Device-Device Incompatibility

  THIS REPORT IS FOR A VETERINARY CASE. THERE WAS NO HUMAN PATIENT INVOLVEMENT. IT WAS REPORTED ON (B)(6) 2021, THE HANDLE WITH MINI QUICK COUPLING IS NO LONGER COUPLING WITH SCREWDRIVER BLADES. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICE. THIS REPORT IS FOR ONE (1) CRUCIFORM SCREWDRIVER SHAFT WITH HOLDING SLEEVE. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12040198 ↗
• MalfunctionMar 23, 2021Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A CASE, THE CRUCIFORM SCREWDRIVER WOULD NOT PICK UP THE SCREW. IT SEEMS TO BE BROKEN. PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) CRUCIFORM SCREWDRIVER SHAFT WITH HOLDING SLEEVE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11557960 ↗
• MalfunctionAug 10, 2020Break; Break

  IT WAS REPORTED ON (B)(6) 2020, A CRUCIFORM SCREWDRIVER SHAFT WITH HOLDING SLEEVE WAS RECEIVED. THE OUTSIDE OF THE ITEM WAS INTACT BUT THE CRUCIFORM SCREWDRIVER SHAFT WITH HOLDING SLEEVE ITSELF WAS BROKEN AND NOT ABLE TO BE USED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR 1 CRUCIFORM SCREWDRIVER SHAFT WITH HOLDING SLEEVE THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10386742 ↗
• MalfunctionJul 1, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION, IT WAS OBSERVED THAT SCREWDRIVER SHAFT WITH HOLDING SLEEVE WAS NOT MATING. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8749320 ↗
• MalfunctionMay 9, 2019Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THE MEDICAL DEVICE REPROCESSING (MDR) STAFF INDICATED THAT A CRUCIFORM SCREWDRIVER SHAFT WITH HOLDING SLEEVE WAS WORN, DAMAGED AND NO LONGER PROPERLY ATTACHED TO THE SCREW. THE PRODUCT WAS NO LONGER FUNCTIONAL. IT IS UNKNOWN WHERE THE ISSUE WAS DISCOVERED. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) CRUCIFORM SCREWDRIVER SHAFT WITH HOLDING SLEEVE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8596463 ↗