NA 399.06Recalls & reported problems
Synthes GmbH · REDUCTION FORCEPS 180MM SPEED LOCK · 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 10886982202260), received between Nov 19, 2019 and Apr 26, 2021 — 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.
Most reported problems
Device problems
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 26, 2021Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE TRAUMA PROCEDURE, THE REDUCTION FORCEPS WAS BROKE. ALL FRAGMENTS ARE RETRIEVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) REDUCTION FORCEPS 180MM SPEED LOCK. THIS REPORT IS 1 OF 1 (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11723943 ↗MalfunctionNov 19, 2019Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE THREE CLAMPS OSTEOTOME, MALLEOLAR FORCEPS WITH TWO POINTS AND REDUCTION FORCEPS SPEED LOCK WERE MISSING THE OUTER NUT THAT HOLDS THE SPIN DOWN NUT IN. THEY HAD ALL BEEN BROKEN. THE ISSUE WAS FOUND OUT DURING AN INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS 180MM SPEED LOCK. THIS IS REPORT 3 OF 3 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9342383 ↗
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 16, 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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