NA 03.809.941Recalls & reported problems
Synthes GmbH · UNIVERSAL ARM · Class 1
Data updated Oct 13, 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 10705034726830), received between Mar 23, 2021 and May 6, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 6, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE KNOB TO TIGHTEN/LOOSEN ARM NO LONGER WORKS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO GENERATION OF FRAGMENTS.
Patient problems: Insufficient Information
MAUDE report 21970197 ↗MalfunctionMar 18, 2024Mechanical Problem; Mechanical Problem
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: DURING SURGERY THE ORACLE RETRACTOR ARM BECAME STUCK IN POSITION AND COULDN'T BE MANEUVERED. THIS WAS PART OF THE LOAN SET THE PROCEDURE WAS COMPLETED WITH NO DELAY OR ADVERSE PATIENT OUTCOME. THIS REPORT IS FOR ONE UNIVERSAL ARM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18922034 ↗MalfunctionMar 23, 2021Mechanical Problem; Mechanical Problem
IT WAS REPORTED ON (B)(6) 2021, THAT TWO (2) TORQUE WRENCH NEED TO BE RECALIBRATED AND ONE (1) RIGID ARM NEEDS REPAIR. THE WRENCHES WERE TESTED AT THE OFFICE FOR FIT, FORM AND FUNCTION (FFF). THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) UNIVERSAL ARM. THIS REPORT IS 3 OF 3 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11556510 ↗
Other CLAMP devices
- ATTUNE 2544-00-001Depuy (Ireland) · CLAMP144 reports
- NA 2178-63-134Depuy (Ireland) · CLAMP137 reports
- ATTUNE 2545-01-055Depuy (Ireland) · CLAMP128 reports
- SPECIALIST 86-5035Depuy (Ireland) · CLAMP101 reports
- SPECIALIST 96-6670Depuy Orthopaedics, Inc. · CLAMP92 reports
- Centurion I68080Centurion Medical Products Corporation · CLAMP1 recall0 reports
- Centurion I68095Centurion Medical Products Corporation · CLAMP1 recall0 reports
- Centurion ZC110STCenturion Medical Products Corporation · CLAMP1 recall0 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page