Arthrex® AR-8827-16Recalls & reported problems
Arthrex, Inc. · LO-PRO SCRW TM SS 2.7X 16MMCORTEX · 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 00888867046764), received between Jul 8, 2025 and Jul 8, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Defective Device” (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
- Adverse Event Without Identified Device or Use Problem1
- Defective Device1
Patient problems
- Bone Fracture(s)1
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 8, 2025Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem
ON 04/07/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-8973L-38-130 ARTHREX FIBULOCK NAIL, 3.8 X 130 MM LEFT, HAD BROKEN AT THE PROXIMAL SYNDESMOTIC TIGHTROPE HOLE. THE PATIENT HAD A POST-OPERATIVE BREAK IN THE FIBULAR NAIL, REQUIRING ITS REMOVAL DURING AN ANKLE FRACTURE PROCEDURE ON (B)(6) 2025. THE BROKEN FRAGMENTS WERE SUCCESSFULLY RETRIEVED. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 5/21/2025: ON (B)(6) 2025, AN ORIF ANKLE SURGERY WAS PERFORMED UTILIZING AR-8973L-38-130 ARTHREX FIBULOCK NAIL, AN AR-8973DS FIBULOCK IMPLANT SYSTEM, AN AR-8827-16 LOW PROFILE SCREW, AN AR-8827-18 LOW PROFILE SCREW, TWO AR-8925SS SYNDESMOSIS TIGHTROPE XP, AND AN AR-8934BCST-2 DOUBLE LOADED SUTURETAPE S-TAK ASSY. FOLLOWING THE SURGERY, IT WAS DETERMINED THAT THE FIBULAR NAIL HAD BROKEN, REQUIRING AN ADDITIONAL PROCEDURE TO STABILIZE THE FRACTURE. FOLLOWING THE SURGERY, IT WAS DETERMINED THAT THE FIBULAR NAIL HAD BROKEN, REQUIRING AN ADDITIONAL PROCEDURE TO STABILIZE THE FRACTURE. THE REVISION SURGERY TOOK PLACE APPROXIMATELY TWO WEEKS AFTER THE INITIAL PROCEDURE. DURING THE REVISION, THE BROKEN FIBULAR NAIL WAS REMOVED AND REPLACED WITH AN ARTHREX TTC NAIL T
Patient problems: Bone Fracture(s); Failure of Implant
MAUDE report 22438828 ↗
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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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