NA 03.900.002Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982080646), received between Jun 17, 2020 and Oct 1, 2024 — classified as 4 malfunctions.

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

• MalfunctionOct 1, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024 THE PIECE LENGTHENING EXTENDER FOR SCREWDRIVER SHAFT BROKE DURING A REMOVAL CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 20344840 ↗
• MalfunctionNov 13, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED VIA FEEDBACK FROM OR STAFF THAT THE T8 DRIVER REQUIRED REPLACING DUE TO DIFFICULTY ENGAGING WITH SCREW HEADS. IT WAS ALSO REPORTED THAT OTHER ITEMS NEEDED TO BE INSPECTED DURING THE SALES REP VISIT. AFTER INSPECTION FROM THE SALES REP WAS COMPLETED, OTHER ITEMS WERE FOUND REQUIRING REPLACEMENT DUE TO THEIR BEING WORN. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN AO COUPLING EXTENSION SHAFT. THIS IS REPORT 4 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18123129 ↗
• MalfunctionOct 2, 2023Use of Device Problem; Use of Device Problem

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2023 DURING LOAN KIT INSPECTION, THE SPRING WAS FOUND TO BE MISSING FROM THE SCREWDRIVER SHAFT. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR AN AO COUPLING EXTENSION SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17853210 ↗
• MalfunctionJun 17, 2020Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN REVISION/REMOVAL PROCEDURE ON AN UNKNOWN DATE THE AO COUPLING EXTENSION SHAFT BROKE OFF. NO FURTHER INFORMATION PROVIDED. THIS COMPLAINT IS FOR ONE (1) AO COUPLING EXTENSION SHAFT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10163127 ↗