NA 03.211.431Recalls & reported problems
Synthes GmbH · CENTERING PIN 1.6MM FOR REDUCTION JOYSTICK/5.0MM · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982076380), received between Apr 1, 2022 and Jul 10, 2025 — classified as 2 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.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2025Break; Break
IT WAS REPORTED THAT DURING THE SURGERY, THE 1.6 CENTERED NEEDLE WAS BROKEN AND THE PALAN-REDUC 5 WAS ALSO BENT. IT WAS SOLVED BY PASSING THE OTHER PALAN-REDUC. THERE WAS NO EXTRA TIME FOR THIS, AND IT DID NOT AFFECT THE PATIENT. THE SURGERY ENDED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22468099 ↗MalfunctionApr 1, 2022Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT WHEN THE INSTRUMENTS WERE TO BE POSITIONED, THE CENTERING GUIDE BROKE WITHOUT CAUSING DAMAGE TO THE PATIENT. THIS REPORT IS FOR ONE (1) CENTER-PIN Ø1.6 F/REDUC JOYSTICK Ø5. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13978377 ↗
Other FORCEPS devices
- NA 314.291Synthes GmbH · FORCEPS177 reports
- NA 399.99Synthes GmbH · FORCEPS111 reports
- NA PDL114Synthes GmbH · FORCEPS81 reports
- GEM COUPLER Forceps GEM4183CSynovis Micro Companies Alliance, Inc · FORCEPS1 recall4 reports
- AESCULAP BJ043RAesculap AG · FORCEPS1 recall0 reports
- AESCULAP MD569Aesculap, Inc. · FORCEPS1 recall0 reports
- ATRAUMATA FB483RAesculap AG · FORCEPS1 recall0 reports
- AESCULAP BJ045RAesculap AG · FORCEPS1 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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