Arthrex® AR-8610D-25Recalls & reported problems
Arthrex, Inc. · DRIVER SHAFT, T7 HEXALOBE CANNULATED · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867197268), received between Jul 11, 2022 and Nov 8, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (4 reports).
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.
Reports received per month
Most reported problems
Device problems
- Break4
- Defective Device2
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 8, 2024Break; Break
IT WAS REPORTED THAT DURING A CHEVRONETTE SURGERY THE SCREWDRIVER BROKE AT THE TIP. ALL PARTS COULD BE COMPLETELY REMOVED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20639555 ↗MalfunctionOct 24, 2024Break; Use of Device Problem; Defective Device; Break; Use of Device Problem; Defective Device
IT WAS REPORTED THAT ACCORDING TO THE OPERATING SURGEON, THERE IS A MATERIAL DEFECT IN THE SCREWDRIVER, BECAUSE THE DEVICE WAS USED TODAY AND IS NOW DEFECTIVE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20524764 ↗MalfunctionOct 24, 2024Break; Defective Device; Break; Defective Device
IT WAS REPORTED THAT ACCORDING TO THE OPERATING SURGEON, THERE IS A MATERIAL DEFECT IN THE SCREWDRIVER, BECAUSE THE DEVICE WAS USED TODAY AND IS NOW DEFECTIVE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20524413 ↗MalfunctionJul 11, 2022Break
IT WAS REPORTED THAT DURING A SURGERY FOUR DRIVERS BROKE DURING REMOVAL OF THE SCREW. NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14978546 ↗
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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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