NA 398.83Recalls & reported problems
Synthes GmbH · SELF-CENTERING BONE FORCEPS 23MM SERRATED JAW-SPEED LOCK · Class 1
- 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 10886982201799), received between Oct 12, 2020 and Sep 6, 2024 — 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
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.
MalfunctionSep 6, 2024Break; Break
IT WAS REPORTED THAT ON AUGUST 13, 2024, THE STOP CAP BROKE OFF AT THE END OF THE SPINDLE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A SELF-CENTERING BONE FORCEPS 23MM SERRATED JAW-SPEED LOCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20162383 ↗MalfunctionOct 12, 2020Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SELF-CENTERING BONE FORCEPS BROKE. IT IS UNKNOWN WHERE, OR WHEN THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SELF-CENTERING BONE FORCEPS 23MM SERRATED JAW-SPEED LOCK THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10663430 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.