Arthrex® AR-8740-34HRecalls & reported problems
Arthrex, Inc. · COMPR FT SCRW,4.0 STD,34MM LGTH · 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 00888867127722), received between Jun 27, 2019 and Jun 27, 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 16, 2026.
Most reported problems
Device problems
- Break1
- Material Twisted/Bent1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 27, 2019Break; Material Twisted/Bent
IT WAS REPORTED THAT DURING A PROCEDURE, THE SURGEON WAS ATTEMPTING TO REMOVE A 4.0 HEADLESS SCREW FROM THE PROXIMAL TIBIA WITH A T10 HEXALOBE DRIVER, AR-8737-38, AND THE TIP BROKE OFF INTO THE HEAD OF THE SCREW. THE TIP WAS ABLE TO BE REMOVED FROM THE HEAD WITH NO ISSUE. THE SURGEON THEN USED A CANNULATED T10 HEXALOBE DRIVER, AR-8737-26, TO FINISH THE REMOVAL OF THE TIP OF THE DRIVER WHICH BECAME TWISTED. THE SCREW WAS ABLE TO BE REMOVED WITH THE SECOND DRIVER WITH NO ISSUE TO THE PATIENT. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED (B)(6) 2019: THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2019 WHERE A 4.0 HEADLESS SCREW, AR-8740-34H, WAS IMPLANTED. SHORTLY AFTER, THE PATIENT BEGAN EXPERIENCING PAIN AND HAD TO HAVE A SECOND SURGERY TO HAVE THE SCREW REMOVED ON (B)(6) 2019. PAIN IS THE ONLY SYMPTOM THE PATIENT WAS EXPERIENCING AND IT WAS THE ONLY DEVICE REMOVED DURING THE REVISION PROCEDURE. NO HARDWARE WAS PUT IN ITS PLACE.
Patient problems: Pain
MAUDE report 8739448 ↗
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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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