Arthrex® AR-8827-12SRecalls & reported problems
Arthrex, Inc. · LOW PROFLIE SCREW, CORITCAL, 2.7 X 12 MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867178809), received between Jul 9, 2024 and Jul 9, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON 06/17/2024 IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-8827-12S LOW PROFILE SCREW FELL OUT AND COULD NOT BE IMPLANTED. THIS WAS DISCOVERED DURING AN OPEN REDUCTION OF A FIBULAR FRACTURE PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 6/26/2024: THE AR-8827-12S LOW PROFILE SCREW WAS IMPLANTED BUT IT PULLED OUT. AFTER MULTIPLE ATTEMPTS, THE SURGEON GAVE UP AND DECIDED THE FIXATION WOULD BE FINE WITH THE OTHER SCREWS THAT WERE ALREADY IMPLANTED. THE CASE WAS NOT DELAYED AND ADDITIONAL ANESTHESIA WAS NOT NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19702330 ↗
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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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