NA 03.118.002Recalls & reported problems
Synthes GmbH · LARGE COMPRESSION FORCEPS WITH SPEED LOCK · Class 1
Data updated Oct 16, 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 10886982073310), received between Jan 24, 2017 and Oct 29, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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. 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
- Break3
Patient problems
- No Patient Involvement2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 29, 2024Break; Break
IT WAS REPORTED THAT ON 21-OCTOBER-2024, THE SPRING BAR WAS BROKEN. NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 20558779 ↗MalfunctionSep 18, 2018Break; Break
IT WAS REPORTED THAT ON (B)(6) 2018, THE SCRUB TECHNICIAN NOTED THAT ONE (1) LARGE COMPRESSION FORCEPS WITH SPEED LOCK WAS BROKEN WHILE OPENING THE SET FOR OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE ANKLE. THIS WAS NOTED DURING THE SET-UP OF THE CASE. THE INSTRUMENT THAT WAS NEEDED FOR THE CASE. THE CASE PROCEEDED AS NORMAL, WAS NOT DELAYED, AND WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) LARGE COMPRESSION FORCEPS WITH SPEED LOCK. THIS IS REPORT 1 OF 6 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 7886772 ↗MalfunctionJan 24, 2017Break; Break
DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SPRING ON THE COMPRESSION FORCEPS WAS IDENTIFIED AS BEING BROKEN WHEN PACKING THE SET AFTER BEING STERILIZED. THE INSTRUMENT HAD NOT BEEN USED FOR THE PREVIOUS PROCEDURE; IT WAS IN A SET THAT HAD BEEN OPENED FOR USE. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE DEVICE BREAKAGE. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).
Patient problems: No Patient Involvement
MAUDE report 6273940 ↗
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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