Arthrex® AR-8916VNC-18SRecalls & reported problems
Arthrex, Inc. · 2.4X18MM 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 00888867242623), 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
ON 10/08/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-8916VNC-18S VAL NEAR CORTEX SCREW (2.4 MM X 18 MM), AR-8916VNC-16S VAL NEAR CORTEX SCREW (2.4 MM X 16 MM), AR-8916VNC-14S VAL NEAR CORTEX SCREW (2.4 MM X 14 MM), AND AN AR-8916VNR-03S VOLAR DISTAL RADIUS PLATE WERE IMPLANTED IN THE PATIENT DURING SURGERY TO REPAIR A DISTAL RADIUS FRACTURE ON (B)(6) 2025. DURING POSTOPERATIVE FOLLOW-UP, IT WAS CONFIRMED THAT THREE SCREWS IN THE DISTAL-MOST ROW HAD LOOSENED. NO FURTHER DISPLACEMENT WAS OBSERVED DURING FOLLOW-UP, AND THE PATIENT REPORTEDLY HEALED WITHOUT INCIDENT. AS PART OF THE TREATMENT PLAN AFTER HEALING, THE SCREWS WERE REMOVED ON (B)(6) 2025 FOR A DISTAL RADIUS FRACTURE REPAIR PROCEDURE. THE LOOSE SCREWS WERE IDENTIFIED AS AR-8916VNC-18S VAL NEAR CORTEX SCREW (2.4 MM X 18 MM), AR-8916VNC-16S VAL NEAR CORTEX SCREW (2.4 MM X 16 MM), AND AR-8916VNC-14S VAL NEAR CORTEX SCREW (2.4 MM X 14 MM). THE PLATE PART NUMBER WAS AR-8916VNR-03S VOLAR DISTAL RADIUS PLATE. THE SURGERY WAS COMPLETED WITHOUT ISSUES USING A PRODUCT WITH THE SAME PART NUMBER. NO SPECIFIC DETAILS WERE PROVIDED REGARDING THE BONE PREPARATION OR BONE QUALITY. NO SIGNIFICANT DELAY OR ADDITIONAL AN
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 23435428 ↗
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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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