Arthrex® AR-8770-80HRecalls & reported problems
Arthrex, Inc. · COMPR FT SCRW, 7.0 XL, 80MM LGTH · Class 2 · Implant
Data updated Oct 18, 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 00888867263314), received between Nov 6, 2019 and Nov 6, 2019 — 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 18, 2026.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Break1
Patient problems
- Impaired Healing1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 6, 2019Break; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED DURING A PROCEDURE WHILE INSERTING A 6.5 HEADLESS COMPRESSION SCREW THE TIP OF THE AR-8610D-65 T25 HEXALOBE CANNULATED DRIVER SHAFT BROKE OFF IN THE SCREW. THE REP REPORTED THE PIECES WERE RECOVERED FROM THE PATIENT AND A SOLID DRIVER FROM THE 5.0/7.0 COMPRESSION FT SET WAS USED TO FINISH INSERTING THE SCREW, AND THE CASE WAS COMPLETED. ADDITIONAL INFORMATION RECEIVED ON 09/27/2019: THE REP REPORTED THE PROCEDURE TAKING PLACE WAS A REVISION SUBTALAR FUSION. THE REASON FOR THE REVISION WAS DUE TO A NON-UNION OF SUBTALAR FUSION. THE REP STATED THE BROKEN DRIVER TIP WAS FULLY REMOVED FROM THE HEAD OF THE SCREW. IT WAS REPORTED THAT THE SCREW WAS NOT DAMAGED OR AFFECTED IN ANY WAY, AND REMAINS IMPLANTED IN THE PATIENT. THE DRIVER IS AVAILABLE TO RETURN FOR EVALUATION. HOWEVER, THE RETRIEVED BROKEN PIECES WERE DISCARDED AND WILL NOT BE RETURNING. THE DRIVER CAME IN SET AR-8610S-02 / SN: (B)(4). ADDITIONAL INFORMATION RECEIVED ON 09/30/2019: THE REP REPORTED A QUANTITY TWO ARTHREX 7.0 COMPRESSION FT SCREWS WERE REMOVED DURING THE REVISION PROCEDURE. THE REP STATED AT THIS TIME THEY DO NOT HAVE THE PART AND/OR LOT NUMBERS OF THE EXPLANTED SCREWS NOR ANY ADDITIONAL DETAILS
Patient problems: Impaired Healing; Pain
MAUDE report 9286572 ↗
Other Plate, fixation, bone devices
- Lapiplasty System 2 SK14Treace Medical Concepts, Inc. · Plate, Fixation, Bone260 reports
- PRECICE® Plating System LP4.5-PRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls6 reports
- PRECICE® Plating System LP4.5-MLT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls5 reports
- PRECICE® Plating System LP4.5-MRT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-PLF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
- PRECICE® Plating System LP4.5-MLT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- PRECICE® Plating System LP4.5-MRT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page