NA 359.224Recalls & reported problems
Synthes GmbH · LOCKING PLIERS-LONG · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982197252), received between Apr 7, 2023 and Apr 7, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Entrapment of Device” (1 report).
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
- Entrapment of Device1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 7, 2023Entrapment of Device; Entrapment of Device
IT WAS REPORTED THAT ON (B)(6) 2023 THE METAL SHAVING CAME OFF INSTRUMENT. SHAVINGS OF METAL FROM PLIERS CAME OFF INTO PATIENT, UNKNOWN IF THOSE FRAGMENTS WERE REMOVED. THERE WERE NO SURGICAL DELAY. SURGERY WAS COMPLETED SUCCESSFULLY. THIS COMPLAIN INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) LOCKING PLIERS-LONG THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: Foreign Body In Patient
MAUDE report 16703389 ↗
Other PLIERS, SURGICAL devices
- NA 391.962Synthes GmbH · PLIERS, SURGICAL36 reports
- NA 03.130.270Synthes GmbH · PLIERS, SURGICAL34 reports
- NA 388.50Synthes GmbH · PLIERS, SURGICAL23 reports
- Axle Interspinous Fusion System X060-1520Xtant Medical Holdings, Inc. · Pliers, Surgical19 reports
- NA 388.509Synthes GmbH · PLIERS, SURGICAL14 reports
- VA-LCP 03.211.005Synthes GmbH · PLIERS, SURGICAL6 reports
- NA 391.82Synthes GmbH · PLIERS, SURGICAL5 reports
- NA 391.88Synthes GmbH · PLIERS, SURGICAL4 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.