NA 311.03Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10887587035680), received between Dec 11, 2019 and Jan 11, 2023 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 11, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE REAMING ROD IN QUESTION WAS BENT, THE DENTAL PICK BROKE OFF, AND THE INNER MECHANISM OF THE DRIVE CAP FELL OUT DURING MALLETING. THE HANDLE AND XL25 BROKE FROM MALLETING THE DRIVER. THE PROCEDURE WAS DELAYED, BUT COMPLETED SUCCESSFULLY. THERE WERE NO REPORTED ADVERSE PATIENT OUTCOMES. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR A HANDLE W/MINI QUICK COUPLING, SMALL. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16137399 ↗
• MalfunctionJan 11, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE REAMING ROD IN QUESTION WAS BENT, THE DENTAL PICK BROKE OFF, AND THE INNER MECHANISM OF THE DRIVE CAP FELL OUT DURING MALLETING. THE HANDLE AND XL25 BROKE FROM MALLETING THE DRIVER. THE PROCEDURE WAS DELAYED, BUT COMPLETED SUCCESSFULLY. THERE WERE NO REPORTED ADVERSE PATIENT OUTCOMES. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR A HANDLE W/MINI QUICK COUPLING, SMALL. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16137398 ↗
• MalfunctionJan 11, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE REAMING ROD IN QUESTION WAS BENT, THE DENTAL PICK BROKE OFF, AND THE INNER MECHANISM OF THE DRIVE CAP FELL OUT DURING MALLETING. THE HANDLE AND XL25 BROKE FROM MALLETING THE DRIVER. THE PROCEDURE WAS DELAYED, BUT COMPLETED SUCCESSFULLY. THERE WERE NO REPORTED ADVERSE PATIENT OUTCOMES. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR A HANDLE W/MINI QUICK COUPLING, SMALL. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16137391 ↗
• MalfunctionOct 14, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREWDRIVER BLADE WAS STUCK INSIDE THE SCREWDRIVER HANDLE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) HANDLE W/MINI QUICK COUPLING, SMALL. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10679342 ↗
• MalfunctionDec 11, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019 DURING A FRACTURE SURGERY THE HANDLE WITH MINI QUICK COUPLING WOULD NOT GRIP ONTO AN UNKNOWN SCREWDRIVER SHAFT. THE SURGERY WAS COMPLETED WITHOUT SURGICAL DELAY BY USING A BACK UP DEVICE THAT WAS AVAILABLE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. CONCOMITANT DEVICE: UNKNOWN SCREWDRIVERS: SHAFTS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE HANDLE W/MINI QUICK COUPLING, SMALL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9451860 ↗