Arthrex® AR-1403TCRecalls & reported problems
Arthrex, Inc. · BIO-COMPR INTERF SCRW,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 00888867016545), received between Nov 3, 2025 and Nov 3, 2025 — classified as 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Damaged Thread1
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.
MalfunctionNov 3, 2025Damaged Thread; Damaged Thread
ADDITIONAL INFORMATION WAS PROVIDED BY SALES REP ON 03-NOV-25 THAT THIS WAS DISCOVERED DURING A KNEE CASE AND A LIGAMENT RECONSTRUCTION WITH TIBIAL OSTEOTOMY WAS PERFORMED. A TAP WAS USED TO THREAD THE TUNNEL AND THE BONE QUALITY OF THE PATIENT WAS GOOD. THE IMPLANT DID NOT BREAK, ONLY LOST THE INITIAL THREAD. A GRAFT FROM THE FLEXOR AND FIBULAR TENDON WAS USED, RESULTING IN A THICKNESS OF 10MM. THE SURGEON CHOSE TO INSERT A 11X28 MM SCREW, WHICH STRIPPED, SO A SMALLER 10X28 MM HAD TO BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23451475 ↗
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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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