Arthrex® AR-10100Recalls & reported problems
Arthrex, Inc. · ARTICULATING PROBE · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867002531), received between Oct 27, 2023 and Oct 27, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 27, 2023Break; Break
ON 10/3/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-10100 ARTICULATING PROBE HAD AN ISSUE. DURING THE SURGERY, THE DOCTOR WAS INSPECTING THE PATIENT'S KNEE AND WAS USING THE PROBE AND ENDED UP FORCING IT TOO MUCH TESTING THE PATIENT'S TENDONS, SO IT BROKE. THEY REMOVED THE BROKEN TIP FROM THE PATIENT, OBTAINED ANOTHER PROBE FROM THE HOSPITAL, AND WERE ABLE TO COMPLETE THE PROCEDURE. THIS OCCURRED DURING USE IN AN UNSPECIFIED PROCEDURE ON (B)(6) 2023 WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 10/24/2023, THE ARTHREX SUBSIDIARY EMPLOYEE PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: THIS OCCURRED DURING AN ACL WITH MENISCUS SUTURE PROCEDURE. THERE WAS NO DELAY IN THE SURGERY, AS OTHER MATERIAL WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18020197 ↗
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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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