MITEK CRUCIATE+ 219009Recalls & reported problems
Medos International Sàrl · MITEK CRUCIATE+ ACL/PCL Femoral Capture Aimer 2-40mm Plus or Minus 13 Percent · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 10886705025817), received between Jan 14, 2020 and May 8, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Corroded” (1 report).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Corroded1
- Material Twisted/Bent1
- Mechanical Jam1
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE CRUCIATE+ FEMORAL CAPTURE DEVICE HAD THE CRUCIATE CAPTURE ARM GETTING STUCK ON THE CARRIAGE. WE TRIED IT ON ANOTHER CARRIAGE AND IT DID NOT WORK. WE ALSO TRIED THE CARRIAGE WITH A DIFFERENT ARM AND THAT DID WORK, THEREFORE IT WAS JUST THE ARM THAT WAS CAUSING THE ISSUE. NO SURGICAL DELAY OR PATIENT HARM. OPENED ANOTHER TRAY TO COMPLETE THE CASE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21987166 ↗MalfunctionSep 11, 2020Corroded; Corroded
IT WAS REPORTED BY THE AFFILIATE VIA COMPLAINT SUBMISSION TOOL THAT WHILE INSPECTING THE ORTHOKIT, IT WAS FOUND THAT THE ARTICLES IN THE LENDING SET WERE RUSTING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10522458 ↗MalfunctionJan 14, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED BY THE SALES REP VIA CST THAT DURING AN ACL PROCEDURE THE PIN OF THE CRUCIATE AND FEMORAL CAPTURE CAME OUT INFERIOR TO THE NORMAL POSITION. THE SURGEON BELIEVES THE GUIDE MAY BE BENT TO THE LACK OF ACCURACY. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9587501 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
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- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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