Arthrex® AR-8916VNC-16SRecalls & reported problems
Arthrex, Inc. · 2.4X16MM VAL NEAR CORTEX SCREW, Ti, STRL · 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 00888867242616), received between Oct 31, 2025 and Oct 31, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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
- Loosening of Implant Not Related to Bone-Ingrowth1
- Patient Device Interaction Problem1
Patient problems
- Failure of Implant1
- 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.
InjuryOct 31, 2025Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth
ADDITIONAL INFORMATION WAS RECEIVED ON 10/14/2025: THE LOOSENING WAS IDENTIFIED DURING A ROUTINE FOLLOW-UP AND WAS NOT ASSOCIATED WITH ANY PATIENT SYMPTOMS SUCH AS PAIN OR SWELLING. NO INTRAOPERATIVE ISSUES WERE REPORTED DURING THE ORIGINAL SURGERY ON (B)(6) 2025. THE SPECIFIC DATE WHEN THE LOOSENING WAS FIRST DETECTED IS UNKNOWN. NO ADDITIONAL INTERVENTIONS, SUCH AS MEDICATIONS OR TREATMENTS, WERE REQUIRED PRIOR TO THE PLANNED SCREW REMOVAL. THE PATIENT IS CURRENTLY IN GOOD HEALTH, AND NO FURTHER SURGERIES ARE PLANNED IN RELATION TO THIS ISSUE. THE REMOVAL OF THE THREE SCREWS AND THE PLATE WAS PERFORMED AS PART OF A PLANNED PLATE REMOVAL SURGERY, IN ACCORDANCE WITH THE PATIENT¿S RECOVERY PROGRESS. ADDITIONAL INFORMATION WAS RECEIVED ON 11/04/2025: THE PART NUMBER AR-8916VNC-14S VAL NEAR CORTEX SCREW (2.4 MM X 14 MM) WAS INCORRECT FOR THIS ALLEGATION. THE CORRECT PART NUMBER IS AR-8916VNC-18S VAL NEAR CORTEX SCREW (2.4 MM X 18 MM). A TOTAL OF TWO AR-8916VNC-18S VAL NEAR CORTEX SCREWS (2.4 MM X 18 MM) WERE INVOLVED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 23435425 ↗
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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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