NA 03.211.455Recalls & reported problems
Synthes GmbH · REDUCTION JOYSTICK/6.5MM · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982076472), received between Feb 27, 2023 and Oct 31, 2025 — classified as 3 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Contamination /Decontamination Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2025, THREE INSTRUMENTS BROKE. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23439670 ↗MalfunctionFeb 7, 2024Break; Break
DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE 6.5 REDUCTION LEVER WAS BROKEN WHEN USED IN SURGERY. THE FRAGMENT WAS REMOVED FROM THE PROCEDURE. THIS REPORT IS FOR ONE (1) REDUCTION JOYSTICK/6.5MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18664231 ↗MalfunctionFeb 27, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT FEBRUARY 6, 2023, DURING THE INSPECTION THE ITEMS WERE FOUND CONTAMINATED ONE(1) DAY PRIOR TO THE SURGERY. THIS REPORT IS FOR ONE (1) REDUCTION JOYSTICK/6.5MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16443822 ↗
Other BIT, SURGICAL devices
- Tornier Perform MWJ127Tornier, Inc. · BIT, SURGICAL114 reports
- NA 310.534Synthes GmbH · BIT, SURGICAL64 reports
- NA 4200355042Stryker Corporation · BIT, SURGICAL34 reports
- ACUFEX 72204044Smith & Nephew, Inc. · BIT, SURGICAL25 reports
- NA 03.168.011Synthes GmbH · BIT, SURGICAL20 reports
- ACUFEX 72204042Smith & Nephew, Inc. · BIT, SURGICAL19 reports
- ACUFEX 72204046Smith & Nephew, Inc. · BIT, SURGICAL16 reports
- ACUFEX 72204045Smith & Nephew, Inc. · BIT, SURGICAL14 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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