Arthrex® AR-8916VNC-16Recalls & reported problems
Arthrex, Inc. · 2.4 X 16MM VAL NEAR CORTEX SCREW, Ti · 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 00888867130722), received between Dec 27, 2017 and Dec 27, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Bent” (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.
Most reported problems
Device problems
- Bent1
- Device Dislodged or Dislocated1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 27, 2017Bent; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT DISTAL RADIUS FRACTURE PROCEDURE ON (B)(6) 2017 WHERE A VOLAR DISTAL RADIUS PLATE (AR-8916VSL-03) WAS IMPLANTED ALONG WITH 5 CORTEX SCREWS. THE PATIENT AFTER INITIAL IMPLANTATION RETURNED HOME AND REPORTS NO FURTHER ISSUES UNTIL FOLLOW UP WITH THE SURGEON. ON (B)(6) 2017, A REVISION WAS PERFORMED TO EXPLANT THE VOLAR DISTAL RADIUS PLATE AND ALL 5 CORTEX SCREWS AS DURING THE PATIENT'S POST-OP APPOINTMENT, THE SURGEON FOUND THAT ALL 5 SCREWS WERE BENT AND HAD BACKED OUT OF THEIR RESPECTIVE LOCKING HOLES IN THE DISTAL RADIUS PLATE. THE SURGEON REPORTS THAT PATIENT HAD NO FALLS, EARLY RANGE OF MOTION OR OTHER EVENT THAT COULD HAVE OCCURRED THAT WOULD'VE CAUSED THIS ISSUE, HOWEVER HE BELIEVES THAT THE PATIENT COULD HAVE EXPERIENCED A FALL OR SOME TYPE OF EVENT THAT CAUSED THIS FAILURE TO OCCUR BUT THE PATIENT DOES NOT RELIABLY GIVE A HISTORY OF SUCH. PATIENT IS A FEMALE, (B)(6). THE FOLLOWING DEVICES WERE EXPLANTED DURING THE REVISION SURGERY: AR-8916VNC-14, LOT: 151596 / LINE (B)(4); AR-8916VNC-16, LOT: 95141729 / LINE (B)(4); AR-8916VNC-18, LOT: 95241731 / LINE (B)(4); AR-8935-12, LOT: 10150458 / LINE (B)(4); AR-8935-14, LOT: 10158950
Patient problems: No Code Available
MAUDE report 7147510 ↗
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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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