NA 399.97Recalls & reported problems
Synthes GmbH · REDUCTION FORCEPS WITH POINTS RATCHET 130MM · Class 1
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982203144), received between Jul 31, 2017 and Feb 7, 2023 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (5 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.
Most reported problems
Device problems
- Break5
- Crack1
- Scratched Material1
Patient problems
- No Consequences Or Impact To Patient2
- No Patient Involvement2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 7, 2023Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRODUCT BROKE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS POINTS RATCHET 130. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16313720 ↗MalfunctionMay 27, 2020Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET AT FSL OWENS & MINOR HANOVER, MD SITE, IT WAS OBSERVED THAT THE FORCEPS WAS BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10091915 ↗MalfunctionOct 17, 2019Break; Break
WHEN THE DEVICE WAS RECEIVED IT WAS DETERMINED THE DEVICE WAS NOT A SYNTHES DEVICE AND WILL BE SENT TO THE CORRECT MANUFACTURER FOR FURTHER INVESTIGATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9204800 ↗MalfunctionAug 15, 2018Break; Crack; Scratched Material; Break; Crack; Scratched Material
IT WAS REPORTED THAT ON (B)(6) 2018, THE CENTRAL PROCESSING MANAGER PRESENTED ONE (1) PERIOSTEAL ELEVATOR CURVED BLADE-ROUND EDGE, ONE (1) PERIOSTEAL ELEVATOR CURVED BLADE-STRAIGHT EDGE, ONE (1) CRUCIFORM SCREWDRIVER, AND ONE (1) REDUCTION FORCEPS WITH POINTS RATCHET THAT WERE CRACKED OR BROKEN. IT WAS UNKNOWN WHEN THE DEVICES BECAME DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS WITH POINTS RATCHET 130MM. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).
Patient problems: No Patient Involvement
MAUDE report 7784408 ↗MalfunctionJul 31, 2017Break; Break
DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE TIP OF THE REDUCTION FORCEPS WITH POINTS RATCHET IS BROKEN. IT IS NOT KNOWN HOW THE DEVICE WAS BROKEN. NO PATIENT INVOLVEMENT WAS REPORTED. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS WITH POINTS RATCHET. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 6755534 ↗
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.