GENESIS 114968Recalls & reported problems
Smith & Nephew, Inc. · GENESIS PIN AND DRILL SET · Class 2
All models of GENESIS (14)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010051332), received between Jul 29, 2022 and Dec 8, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture2
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 8, 2023Fracture; Fracture
IT WAS REPORTED THAT, AFTER A TKA SURGERY, IT WAS NOTICED WITH AN X-RAY THAT THE DRILL PIN TIP HAD BROKEN OFF DURING SURGERY AND WAS BURIED INSIDE OF THE PATIENT. THE BROKEN PIECE HAS NOT BEEN RETRIEVED FROM PATIENT. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.
Patient problems: Foreign Body In Patient
MAUDE report 18291549 ↗InjuryJul 29, 2022Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, A GENESIS PIN AND DRILL SET BROKE WHEN THE SURGEON WAS DRILLING THE HOLES, PRIOR TO PINNING TO SECURE AND FINISH THE TIBIAL REAM. THE BROKEN PART COULD NOT BE REMOVED AND REMAINED IN THE PATIENT'S TIBIA. SURGERY WAS FINISHED WITHOUT FURTHER USAGE OF THE DRILL. NO SIGNIFICANT DELAYS REPORTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.
Patient problems: Foreign Body In Patient
MAUDE report 15136635 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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