EVOS 71175088Recalls & reported problems
Smith & Nephew, Inc. · SPIN REDUCTION FORCEPS - BOWED 205MM · Class 1
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556636718), received between Feb 5, 2021 and Apr 18, 2021 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Twisted/Bent3
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 18, 2021Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT, DURING TRAUMA INTERTAN SURGERY THE COMPRESSION SCREW HEXDRIVER BENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY, WITH THE SAME DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11683504 ↗MalfunctionApr 18, 2021Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT TWO SPIN REDUCTION FORCEPS - BOWED 205 MM WERE NOTICED WITH THE TIPS POINT BENT. NO CASE INVOLVED THEREFORE NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11683501 ↗MalfunctionApr 18, 2021Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT TWO SPIN REDUCTION FORCEPS - BOWED 205MM WERE NOTICED WITH THE TIPS POINT BENT. NO CASE INVOLVED THEREFORE NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11683499 ↗MalfunctionFeb 5, 2021Break; Break
IT WAS REPORTED THAT DURING A TRAUMA CASE THE SPIN REDUCTION FORCEPS - BOWED 205 MM BROKE. THIS HAPPENED OUTSIDE THE PATIENT. NO INJURY, NO DELAY. S+N BACKUPS TO ALL. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11283957 ↗
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.