Arthrex® AR-8545-32Recalls & reported problems
Arthrex, Inc. · LOW PROFILE SCREW, TI, 4.5 X 32MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867124547), received between Feb 22, 2017 and Jul 24, 2018 — classified as 2 injuries.
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
- Detachment Of Device Component1
- Detachment of Device or Device Component1
Patient problems
- Failure of Implant2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 24, 2018Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANKLE FUSION CASE, THE HEAD OF THE SCREW AR-8545-32 POPPED OFF THE BASE OF THE SCREW. THE BASE OF THE SCREW REMAINS IN THE PATIENT. THE SCREW HAD ALREADY BEEN IMPLANTED; THE SURGEON WAS IMPLANTING ANOTHER SCREW; PER THE REP WHO WAS PRESENT, THE AR-8548-32 SCREW WAS IN THE COMPRESSION HOLE AND UNDER PRESSURE WHEN THE OTHER SCREW WAS BEING INSERTED. THE CASE WAS COMPLETED WITH NO ADDITIONAL INCISIONS NEEDED.
Patient problems: Failure of Implant
MAUDE report 7713408 ↗InjuryFeb 22, 2017Break; Detachment Of Device Component
IT WAS REPORTED THAT THE 4.5 MM X 32 M TITANIUM LOW PROFILE SCREW, AR-8545-32, WAS BEING USED IN AN ANKLE FUSION WITH AN ANTERIOR PLATE. THE BONE WAS PREPARED BY USING A 3.0 MM DRILL. THE SCREW WAS BEING INSERTED INTO THE PATIENT BY USING A T-20 DRIVER. WHILE THE SCREW WAS BEING INSERTED BY HAND INTO THE BONE THE SCREW SNAPPED. NO EXTRA TORQUE WAS INVOLVED. THE SCREW HEAD SNAPPED-OFF AS THE PLATE WAS BEING BROUGHT DOWN TO THE BONE. THE SCREW HEAD WAS RETRIEVED FROM THE PATIENT BUT THE SCREW SHAFT WAS LEFT FULLY INSERTED INTO THE TIBIA. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT INJURY REPORTED.
Patient problems: Failure of Implant
MAUDE report 6349017 ↗
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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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