Arthrex® AR-1390BRecalls & reported problems
Arthrex, Inc. · BIO-INTERFERENCE SCREW · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867015500), received between Dec 27, 2017 and Sep 11, 2025 — classified as 1 injury, 1 malfunction.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Damaged Thread1
Patient problems
- Cyst(s)1
- 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.
MalfunctionSep 11, 2025Damaged Thread; Damaged Thread
ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA (B)(4) THAT AN AR-1390B BIO-INTERFERENCE SCREW LOST ITS THREAD. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23030934 ↗InjuryDec 27, 2017Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT DEVELOPED A CYST FOLLOWING THE IMPLANTATION OF A BIO-ABSORBABLE SCREW AR-1390B 9 MM X 23 MM, 3 YEARS BEFORE. IMPLANTATION OF THE SCREW ON (B)(6) 2014, REMOVAL ON (B)(6) 2017. HISTOPATHOLOGICAL SAMPLING PERFORMED. FOLLOW-UP INVESTIGATION: THE SURGEON ALSO USED 2 FASTFIX. THE SURGERY WAS AN ACL RECONSTRUCTION. IMPLANTED DEVICES: AR-1555BC, LOT.:1189552; AR-1370B, LOT: 1188967 AND AR-1390B, LOT: 1189199.
Patient problems: Cyst(s)
MAUDE report 7147513 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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