Arthrex® AR-8840-12Recalls & reported problems
Arthrex, Inc. · LO-PRO SCRW,SS 4.0X 12MMCANCLUS · Class 2 · Implant
Data updated Oct 18, 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 00888867047754), received between Apr 18, 2025 and Apr 18, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
ON (B)(6) 2025, A PATIENT REPORTED VIA PHONE A DISLOCATION THAT REQUIRED METAL PARTS TO STABILIZE THE TIBIA. ON (B)(6) 2024, THE PATIENT UNDERWENT AN OPEN RIGHT ANKLE FRACTURE PROCEDURE DURING WHICH AN AR-8943C-10 LOCKING STRAIGHT PLATE, (QTY. 4) OF AN AR-8835-14 LOW PROFILE NONLOCKING SCREW, SS, 3.5 X 14 MM, AN AR-8835-16 LOW PROFILE SCREW, SS, 3.5 X 16 MM, CORTICAL, AN AR-8840-14 LOW PROFILE SCREW, SS, 4.0 X 14 MM, CANCELLOUS, AN AR-8840-12 LOW PROFILE SCREW, SS, 4.0 X 12 MM, CANCELLOUS, (QTY. 2) OF AN AR-8925SS SYNDESMOSIS TIGHTROPE XP, STAINLESS STEEL, AND AN (QTY 2) OF AN AR-1322BNF SUTURE ANCHOR, MINI BIO-SUTURETAK 2.4 X 8.5 MM WITH 2-0 FIBERWIRE WITH TWO TAPER POINT NEEDLES WERE IMPLANTED. THE PATIENT HAS REPORTED AN ALLERGIC REACTION AFFECTING THE ENTIRE LEG INTERNALLY AND EXTERNALLY, CAUSING SIGNIFICANT SWELLING AND INTENSE PAIN. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 4/15/2025: THE PATIENT IS UNABLE TO CONFIRM WHETHER THE REACTION IS ALLERGY-RELATED UNTIL THE METAL IS REMOVED, WHICH IS SCHEDULED WITHIN THE NEXT TWO WEEKS. THE PATIENT HAS A DOCUMENTED HISTORY OF SURGICAL STAINLESS-STEEL ALLERGY AND A CONFIRMED NICKEL ALLERGY. NO FURTHER INFORMATION HAS BEEN REPOR
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 21865612 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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