Tornier Perform MWH602Recalls & reported problems
Tornier, Inc. · Neo-Reamer Drive Shaft · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00846832070541), received between Jun 18, 2024 and Apr 2, 2026 — classified as 2 malfunctions.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 2, 2026Fracture
THE REAMER FRACTURED AT THE DRIVE END DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24765834 ↗MalfunctionJun 18, 2024Break; Fracture; Break; Fracture
AS REPORTED: "DRIVE SHAFT SNAPPED INSIDE MWH604 NEOREAMER DRIVE END WHILE REAMING THE GLENOID (BOTH INSTRUMENTS FROM YKAD264-T ON CONSIGNMENT). LATER IN THE OPERATION, THE SURGEON FOUND WIRE BEHIND THE GLENOID BASEPLATE WHICH WAS REMOVED. SURGEON ASKED TO BE ADVISED WHERE THE WIRE HAD COME FROM."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19561923 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.