Arthrex® AR-8750-40HRecalls & reported problems
Arthrex, Inc. · COMPR FT SCRW, 5.0 LG, 40MM 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 00888867262867), received between Mar 9, 2020 and Mar 9, 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 18, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 9, 2020Break
IT WAS REPORTED THAT DURING A SUBTALAR FUSION PROCEDURE, THE SURGEON BROKE THE THREADED TIP OF AR-8750KT INSIDE THE PATIENT¿S TALUS. NO ATTEMPT WAS MADE TO RETRIEVE. THE SURGEON WAS ATTEMPTING TO CHANGE THE POSITION OF THE K WIRE AND WHILST DRILLING OUT ON FORWARD THE TIP WAS ADVANCING WHILST THE SHAFT OF THE K WIRE WAS BEING WITHDRAWN FROM THE PATIENT, HENCE A BREAKAGE IS POSSIBLE. IN THE SAME CASE THE SURGEON INSERTED A NEW AR-8750KT SUCCESSFULLY. HOWEVER, BROKE AN AR-8750-40H INSIDE THE PATIENT. THE SURGEON IS VERY FAMILIAR WITH THIS SYSTEM AND ALL ASPECTS OF THE INSERTION APPEARED TO BE COMPLETED CORRECTLY. SURGEON CONTINUED TO INSERT SCREW EVEN AFTER CONSIDERABLE RESISTANCE WAS ENCOUNTERED; HE DIDN¿T STOP TO REMOVE THE SCREW AND RE-DRILL OR ALTER APPROACH. THE SURGEON DRILLED WITH THE CORRECT 1.6 MM GUIDE WIRE (AR-8750KT), MEASURED WITH DEPTH DEVICE (AR-8750-01), OVER DRILLED WITH 3.2 MM DRILL BIT (AR-8750-09), HAND POWERED PROFILE DRILL (AR-8750-05), INSERTED SCREW BY HAND SCREW DRIVER (AR-8750-03) AND THEN FINISHED WITH SOLID DRIVER (AR-8750-06). THE SURGEON DEMANDED THE SOLID DRILL AFTER TWISTING/ WARPING THE END OF THE CANNULATED DRIVER AFTER EXCESSIVE TORSIONAL FORCE DURI
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9805173 ↗
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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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