Arthrex® AR-1404TCRecalls & reported problems
Arthrex, Inc. · SCRW 12X 28MMFULL THD,BIO-COMP · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867016569), received between Aug 28, 2017 and Aug 28, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Tissue Damage1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 28, 2017Insufficient Device Problem Information
IT WAS REPORTED BY PATIENT THAT SHE HAD SURGERY IN 2009 DURING WHICH TIME ARTHREX BIODEGRADABLE SCREWS WERE IMPLANTED. SINCE THEN PATIENT HAS BEEN EXPERIENCING NUMEROUS ISSUES. PATIENT INDICATED THAT A SURGEON INFORMED HER THAT THE BIODEGRADABLE SCREWS CAUSED HER BONE ITSELF TO DEGRADE AND DETERIORATE. FOLLOW UP INVESTIGATION: IT WAS REPORTED THAT DURING A RIGHT ANTERIOR CRUCIATE LIGAMENT TEAR #2 FIBERWIRE, BIO-TRANSFIX PIN AND BIO-COMPOSITE 28 MM SCREW MEASURE 12 MM IN DIAMETER WERE IMPLANTED. A SURGERY ON (B)(6) 2017 CONSISTED OF A RIGHT KNEE ARTHROSCOPY WITH PARTIAL LATERAL MENISCECTOMY AND EXTENSIVE ARTHROSCOPIC DEBRIDEMENT. SURGERY ON (B)(6) 2017 WAS FOR DIAGNOSTIC ARTHROSCOPY OF THE RIGHT KNEE WITH LIMITED DEBRIDEMENT, OPEN BONE GRAFTING, PROXIMAL TIBIA AND OPEN BONE GRAFTING, DISTAL FEMUR. ON (B)(6) 2017 PATIENT HAD ANOTHER SURGERY, BUT THE DETAILS ARE STILL PENDING FROM PATIENT. FOLLOW UP INVESTIGATION: PER PATIENT, ACL RECONSTRUCTION SURGERY WAS ON (B)(6) 2017. FEMALE (B)(6).
Patient problems: Tissue Damage
MAUDE report 6823437 ↗
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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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