NA 7207301Recalls & reported problems
Smith & Nephew, Inc. · 9 x 25 MM RCI SCREW 2.0 MM CANNULATION. STERILE, 1 PER BOX · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010380647), received between May 7, 2019 and Jun 20, 2023 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
- Device Markings/Labelling Problem1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 20, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE RCI SCREW COULD NOT ENGAGE IN THE TIBIAL TUNNEL. NON-SIGNIFICANT DELAY WAS REPORTED, AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17166655 ↗InjuryNov 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON REGISTRY REVIEW 2021 NEW ZEALAND ACL REGISTRY IMPLANT REPORT, AN UNKNOWN AMOUNT OF PATIENTS REQUIRED A REVISION SURGERY AFTER AN ACL PROCEDURE USING FOURTEEN(14) RCI SCREWS. IT IS UNKNOWN HOW WERE THE EVENTS TREATED/RESOLVED. PATIENTS OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 15867229 ↗MalfunctionMay 7, 2019Device Markings/Labelling Problem
IT WAS REPORTED THAT AFTER AN ACL SURGERY THE STAFF NOTICED THAT THE RCI SCREW USED IN THE PATIENT WAS PAST ITS STERILIZATION EXPIRY DATE BY 24 DAYS. PATIENT OUTCOME IS UNKNOWN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8586769 ↗
Other Screw, fixation, bone devices
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- Control 360 SK12Treace Medical Concepts, Inc. · Screw, Fixation, Bone195 reports
- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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