Tornier Perform MWH605Recalls & reported problems
Tornier, Inc. · Neo-Reamer Handle · Class 1
All models of Tornier Perform (40)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00846832070572), received between Mar 12, 2022 and Oct 12, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break2
- Fracture2
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.
MalfunctionOct 12, 2022Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE AUGMENT REAMER AND IMPACTION TIP BROKE DURING SURGERY. THERE WAS NO REPORT OF ANY DEBRIS LEFT IN THE PATIENT AND THE SURGERY WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15591436 ↗MalfunctionMar 12, 2022Break; Fracture; Break; Fracture
THE PHYSICIAN WAS USING THE PERFORM PLUS REVERSE AUGMENTED REAMER AND WITHOUT ANY EFFORT THERE WAS A LOUD NOISE AND IT BROKE AT THE JUNCTION OF THE THREAD TO THE POWER TOOL ATTACHMENT PIECE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13743390 ↗
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- NA 532.021Synthes GmbH · INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT521 reports
- NA 2570-04-501Depuy (Ireland) · INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT500 reports
- NA 532.110Synthes GmbH · INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT433 reports
- NA 05.001.223Synthes GmbH · INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT397 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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