GENESIS II 71440144Recalls & reported problems
Smith & Nephew, Inc. · GENESIS II HOUSING BOX CHISEL/SIZER · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010214225), received between Jul 6, 2021 and Jun 1, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Fracture3
- Dull, Blunt1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 1, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A TKA SURGERY, THE END OF A GII HOUSING BX CHISEL/SZR BROKE OFF DURING REMOVAL AFTER PREPARING FEMUR. THE INSTRUMENT WAS REMOVED MANUALLY. NO PIECES FELL INSIDE THE WOUND. ALL PARTS WERE ACCOUNTED FOR. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19442188 ↗MalfunctionMay 29, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY, THE GII HOUSING BX CHISEL/SZR BROKE DURING IMPACTION. HIT AGAINST AN ACL SCREW. IT IS UNKNOWN HOW WAS COMPLETED THE SURGERY AND IF A DELAY WAS PRESENTED. NO INJURY TO PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19420803 ↗MalfunctionJul 6, 2021Fracture; Dull, Blunt; Fracture; Dull, Blunt
IT WAS REPORTED THAT, A GII HOUSING BX CHISEL/SZR WAS SEVERELY DULLED AND CHIPPED. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO ANY PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12125623 ↗
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- NA 399.56Synthes GmbH · CHISEL, SURGICAL, MANUAL11 reports
- NA 399.55Synthes GmbH · CHISEL, SURGICAL, MANUAL10 reports
- T.L.I.F. 274279000Depuy Spine, LLC · CHISEL, SURGICAL, MANUAL7 reports
- NA 332.121Synthes GmbH · CHISEL, SURGICAL, MANUAL5 reports
- INSTRUMENT 6541-4-709Howmedica Osteonics Corp. · CHISEL, SURGICAL, MANUAL4 reports
- NA 202953Depuy Spine, LLC · CHISEL, SURGICAL, MANUAL4 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.