NA 399.098Recalls & reported problems
Synthes GmbH · REDUCTION FORCEPS W/SERRATED JAW-MEDIUM HANDLE-SOFT RATCHET · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982202345), received between Oct 12, 2017 and Mar 25, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (4 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
- Break4
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2024Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN INDIA AS FOLLOWS: IT WAS REPORTED OF AN INSTRUMENT BREAKAGE. THERE WERE NO PATIENT OUTCOMES OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) REDUC-FORC TOOTHED SOFTLO L194 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18967883 ↗MalfunctionNov 14, 2019Break; Break
IT WAS REPORTED THAT ON (B)(6) 2019 DURING DECONTAMINATION, THE RATCHET SET SCREW OF A REDUCTION FORCEPS FELL OUT. IT IS UNKNOWN IF THERE WAS A PROCEDURE AND PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS W/SERRATED JAW-MEDIUM HANDLE-SOFT RATCHET. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9324117 ↗MalfunctionJul 18, 2018Break; Break
DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A SOFT LOCK PART IS BROKEN. NO PATIENT WAS INVOLVED. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS W/ SERRATED JAW-MEDIUM HANDLE-SOFT RATCHET. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Patient Involvement
MAUDE report 7700926 ↗MalfunctionOct 12, 2017Break; Break
DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE REDUCTION FORCEPS BROKE. THE INSTRUMENT WAS USED IN HUMAN BUT IT IS UNKNOWN IF IT BROKE INTRA-OPERATIVELY OR PRE-OPERATIVELY. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS W/SERRATED JAW-MEDIUM HANDLE-SOFT RATCHET. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6944193 ↗
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 BJ080RAesculap AG · FORCEPS1 recall0 reports
- AESCULAP BJ130RAesculap AG · FORCEPS1 recall0 reports
- AESCULAP BJ132RAesculap 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 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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