Arthrex® AR-1400TRecalls & reported problems
Arthrex, Inc. · SCRW,CANN. INT.,FULL THD · Class 2 · Implant
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 00888867016217), received between Sep 4, 2024 and Sep 4, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Positioning Failure” (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
- Positioning Failure1
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.
MalfunctionSep 4, 2024Positioning Failure; Positioning Failure
ON 08/09/2024, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA SEMS-(B)(4) THAT AN AR-1400T FULL THREAD CANNULATED INTERFERENCE SCREW, WHEN INSERTED IN THE TIBIAL TUNNEL, LOST THE THREAD AND CAME OFF THE SCREW MATERIAL AND BEGAN TO TEAR THE GRAFT (SEE PHOTO ATTACHMENT). ANOTHER IMPLANT WAS USED INSTEAD TO COMPLETE THE CASE. THIS OCCURRED DURING AN LCA PROCEDURE ON (B)(6) 2024, ADDITIONAL INFORMATION WAS RECEIVED ON 09/02/2024: THE AR-1400T FULL THREAD CANNULATED INTERFERENCE SCREW WAS COMPLETELY REMOVED FROM THE PATIENT. THERE WAS NO CASE DELAY REPORTED AND NO ADDITIONAL ANESTHESIA ADMINISTERED. ANOTHER R-1400T FULL THREAD CANNULATED INTERFERENCE SCREW FROM A DIFFERENT LOT WAS USED TO COMPLETE THE CASE. NO ADVERSE EFFECTS ON THE PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20136908 ↗
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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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