Arthrex® AR-8970TTCRecalls & reported problems
Arthrex, Inc. · ANKLE FUSION PLATE, LATERAL TTC · 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 00888867134010), received between Jul 22, 2020 and Jul 22, 2020 — classified as 1 injury.
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.
Most reported problems
Device problems
- Break1
Patient problems
- Failure of Implant1
- Pain1
- Swelling1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 22, 2020Break
IT WAS REPORTED THE PATIENT HAD AN ANKLE FUSION ON (B)(6) 2019 AND THE PATIENT EXPERIENCED PAIN AND SWELLING HAD A FOLLOW UP X-RAY AT THE END OF (B)(6) THAT REVEALED THE AR-8970TTC, ANKLE FUSION PLATE, WAS BROKEN. LOT NUMBER OF THE PLATE WAS UNKNOWN AT THE TIME OF INITIAL REPORT. THE PATIENT HAD TO WAIT UNTIL JUNE TO HAVE A REVISION SURGERY TO REMOVE THE BROKEN PLATE AND SCREWS. THE DOCTOR USED A REVISION ANKLE SUBTALAR FUSION TO REMEDY THE SITUATION. THE PATIENT IS CURRENTLY IN A CAST AND IN A HEALING STATE. ADDITIONAL INFORMATION OBTAINED 7/20/2020: THE ORIGINAL PROCEDURE WAS A TTC FUSION ON (B)(6) 2019. THE REVISION SURGERY TOOK PLACE ON (B)(6) 2020. THE REVISION WAS COMPLETED USING A NAIL. THE SURGEON HAS THE PLATE AND SCREWS AND WILL RETURN THEM TO ARTHREX FOR EVALUATION. THE PATIENT SUFFERED NO KNOWN TRAUMA SINCE THE ORIGINAL PROCEDURE. BOTH ORIGINAL AND REVISION PROCEDURES WERE PERFORMED BY THE SAME SURGEON AT THE SAME FACILITY. SCREW PART NUMBERS ARE NOT KNOWN AT THIS TIME. ADDITIONAL INFORMATION OBTAINED 7/21/2020: THE FOLLOWING ARE THE DEVICES ORIGINALLY IMPLANTED (B)(6) 2019. THE SURGEON CHOSE TO REMOVE ALL OF THE BELOW DEVICES DURING THE REVISION SURGERY: AR-8970TTC, AN
Patient problems: Failure of Implant; Pain; Swelling
MAUDE report 10309706 ↗
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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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