Arthrex® AR-1380BRecalls & reported problems
Arthrex, Inc. · BIO-INTERFERENCE SCREW · 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 00888867015265), received between Jun 11, 2024 and Aug 28, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Damaged Thread” (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
- Damaged Thread1
- Material Deformation1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2024Material Deformation; Material Deformation
ON 08/07/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-1380B BIO-INTERFERENCE SCREW WITH DISPOSABLE SHEATH DOES NOT SCREW IN THE PATIENT'S TENDON. THE SURGEON APPLIED FORCE TO INSERT THE SCREW, BUT IT DID NOT SCREW IN. WHEN THE SCREW WAS REMOVED, IT APPEARED DEFORMED. THIS WAS DISCOVERED DURING A KNEE ARTHROSCOPY AND ACL PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 8/26/2024: UPON REMOVAL OF THE SCREW, IT WAS DEFORMED; HOWEVER, IT DID NOT BREAK IN THE PATIENT. THE ENTIRE SCREW WAS SUCCESSFULLY REMOVED. THE CASE WAS COMPLETED USING AN AR-4030C-09 BIOCOMPOSITE FASTTHREAD INTERFERENCE SCREW. THE CASE WAS DELAYED TEN MINUTES WITHOUT ADDITIONAL ANESTHESIA.
Patient problems: Insufficient Information
MAUDE report 20087194 ↗MalfunctionJun 11, 2024Damaged Thread; Damaged Thread
ON 4/4/2023 IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-1380B BIO-INTERFERENCE SCREW WITH DISPOSABLE SHEATH HAD AN ISSUE. AR-4019D-1 FASTTHREAD SCREW DRIVER FOR 6 MM AND AR-1996CD-1 QUICK CONNECT DRIVER WERE USED TO ANCHOR THE SCREW FOR INSERTION. HOWEVER, WHEN THE SURGEON WAS SCREWING IT IN, THE SCREW DID NOT THREAD ANYMORE. THIS WAS DISCOVERED DURING AN LCA PROCEDURE WITH NO PATIENT HARM. ADDITIONAL INFORMATION IS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19510994 ↗
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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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