LARGE CANNULATED SCREWS 110069Recalls & reported problems
Smith & Nephew, Inc. · CANNULATED REAMER 4.8MM · Class 2
All models of LARGE CANNULATED SCREWS (21)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 03596010033635), received between Jul 15, 2019 and Jul 15, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Component Missing” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K123598); they may or may not involve this specific model.
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
- Component Missing1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 15, 2019Component Missing; Component Missing
IT WAS REPORTED THAT DURING SURGERY THE SCREW DRIVER IN THE SET WAS BROKEN (THE TIP HEX PART WAS NOT THERE) .THERE WAS NO CANNULATED DRILL BIT IN THE SET. THESE ARE TWO ESSENTIAL INSTRUMENTS FOR THE INSERTION OF THESE SCREWS, THE TAP WAS USED TO BREAK THE CORTEX, THE SCREW WAS TURNED IN BY HAND HALF WAY, WHERE THE GUIDE PIN HAD TO BE REMOVED AND THEN INSERTED ALL THE WAY. STRUCTURE WAS ALSO BOOKED (B)(4) BUT MIXING THESE WAS DIFFICULT AND DID NOT WORK WELL EVEN THOUGH INSTRUCTIONS WAS FOLLOWED. THE SURGEON HAD TO REVERT TO OPEN SURGERY AS HE NEEDED TO INSERT THE BONE GRAFT (THE PATIENTS WAS COUNSELED FOR ARTHROSCOPIC SURGERY AS WELL AS CONSENTED, NOT OPEN). INCREASED RISK OF INFECTION DUE TO BONE GRAFT BEING INSERTED BY HAND. LESS THAN 30 MINUTES DELAY WAS REPORTED. THE PATIENT IS NOW SEPTIC AND HAD TO BE TAKEN BACK TO SURGERY FOR A DEBRIDEMENT.
Patient problems: Unspecified Infection
MAUDE report 8791756 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K123598. One submission often covers many models, so check the product and lot details in each record.
- Z-0730-2019 · Jan 7, 2019 · TerminatedSL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
- Z-1008-2017 · Nov 16, 2016 · TerminatedREFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116
Other Prosthesis, hip, femoral component, cemented, metal devices
- GENESIS II 71440005Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal599 reports
- NA 71364073Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal436 reports
- Peri-Loc 71173377Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal401 reports
- R3 71368569Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal398 reports
- NA 71364006Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal197 reports
- NA 71364011Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal176 reports
- Accord 71360046Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal171 reports
- REFLECTION 71362279Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal155 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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