KneeAlign 2 403189Recalls & reported problems
Orthalign, Inc. · Pin Driver, Tri-Flat, 3.2mm · Class 2
All models of KneeAlign 2 (8)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00858704006435), received between Mar 16, 2019 and Nov 13, 2024 — classified as 4 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.
Reports received per month
Most reported problems
Device problems
- Break2
- Insufficient Device Problem Information1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 13, 2024Break; Break
THE PIN DRIVER BROKE DURING SURGERY WHEN TRYING TO REMOVE ONE OF THE TIBILA RESECTOR PINS. THE PIN WAS ABLE TO BE REMOVED WITH A PAIR OF PLIERS. THERE WAS NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20677423 ↗MalfunctionSep 11, 2023Break; Break
THE SURGEON WAS INSERTING SHORT HEADED PINS INTO THE MICROBLOCK AND THE PIN WAS NOT INSERTED IN THE PROPER TRAJECTORY AND THE PIN SNAPPED IN THE PIN DRIVER WHILE TRYING TO FIX TO THE FEMUR. THE PIN WAS STUCK IN THE FEMUR AND HAD TO BE BACKED OUT MANUALLY. THERE WAS NO IMPACT OR INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17725621 ↗MalfunctionApr 26, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT TOTAL KNEE ARTHROPALSTY WAS PERFORMED WITH KNEEALIGN ON (B)(6) 2023. DURING PROCEDURE, AFTER SURGEON ATTACHED A PIN TO THE PIN DRIVER (P/N 403189), HE STARTED DRILLING THE PIN TO THE PATIENT'S FEMORAL BONE. HE FOUND THAT THE PIN AXIS WAS SO ECCENTRIC THAT IT WAS ABOUT TO DAMAGE THE PATIENT'S BLOOD VESSEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16820857 ↗MalfunctionMar 16, 2019No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT BOTH PIN DRIVERS HAD THE HEAD OF THE SMALL HEADED PINS SNAP OFF AND GET STUCK.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8426672 ↗
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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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