NA SD398.400Recalls & reported problems
Synthes GmbH · REDUCTION FORCEPS WITH POINTS NARROW-RATCHET · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982269577), received between Jun 26, 2020 and Jun 26, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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.
Most reported problems
Device problems
- Break1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 26, 2020Break; Break
IT WAS REPORTED THAT ON (B)(6) 2020, THE CLAMP WAS PLACED ON FRACTURE IN ATTEMPT TO REDUCE IT. THE CLAMP TOOTH BROKE WHILE RATCHETING THE CLAMP. THE CLAMP WAS REMOVED. THERE WERE NO FRAGMENTS GENERATED FROM THE BROKEN DEVICE. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) REDUCTION FORCEPS WITH POINTS NARROW-RATCHET. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10199697 ↗
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 BJ025RAesculap AG · FORCEPS1 recall0 reports
- AESCULAP BJ058RAesculap AG · FORCEPS1 recall0 reports
- AESCULAP BJ062RAesculap AG · FORCEPS1 recall0 reports
- ATRAUMATA FB440RAesculap 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 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