Arthrex® AR-1380PRecalls & reported problems
Arthrex, Inc. · PEEK INTERF SCRW W/DISP SHTH 8X 23MM · Class 2 · Implant
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 00888867015326), received between Nov 26, 2024 and Feb 25, 2026 — classified as 2 malfunctions.
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
- Device Dislodged or Dislocated1
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.
MalfunctionFeb 25, 2026Device Dislodged or Dislocated
ON 9TH FEB 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1380P, PEEK INTERFERENCE SCREW, SHEATHED, 8 X 23 MM, ITS ANCHOR WAS PULLED OUT AND COULD NOT BE SET SUCCESSFULLY. THIS WAS DETECTED DURING A RECONSTRUCTION OF ANTERIOR CRUCIATE LIGAMENT SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1380P. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24441695 ↗MalfunctionNov 26, 2024Break; Break
ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-1380P, PEEK INTERFERENCE SCREW, SHEATHED, 8 X 23 MM, THE ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION OF KNEE JOINT SURGERY ON (B)(6) 2024. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS ANOTHER NEW AR-1380P WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20789219 ↗
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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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