Arthrex® AR-8916VNC-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867130739), received between Dec 27, 2017 and Jul 11, 2025 — classified as 1 injury, 2 malfunctions.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2025Use of Device Problem; Defective Device; Use of Device Problem; Defective Device

  ON 6/17/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-8916VNL-03 VOLAR DISTAL RADIUS PLATE AND AN AR-8916VNC-18 SCREW HAD AN ISSUE DURING A DISTAL RADIUS FRACTURE PROCEDURE ON (B)(6) 2025. WHEN THE SURGEON WAS INSERTING THE SCREW, USING A HANDRIVER, HE FELT LIKE THE SCREW WAS NOT WORKING CORRECTLY, AND NOTICED THAT THE SCREW WENT THOUGH THE PLATE DURING INSERTION. THE SURGEON REMOVED THE SCREW AND THE PLATE FROM THE PATIENT. NOTHING BROKE INSIDE THE PATIENT, AND THERE WAS NO HARM. AN X-RAY WAS TAKEN, AND THE COMPLAINT DEVICES WERE AVAILABLE FOR RETURN. ANOTHER AR-8916VNL-03 VOLAR DISTAL RADIUS PLATE AND AN AR-8916VNC-18 SCREW WITH THE SAME LOT NUMBERS WERE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE CASE WAS SLIGHTLY DELAYED BY UNDER 15 MINUTES, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS OCCURRED DURING USE WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22481783 ↗
• MalfunctionJun 19, 2024Positioning Failure; Positioning Failure

  ON 1/24/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8916VNC-18 LOW PROFILE LOCKING SCREW WAS INSERTED INTO THE PLATE BUT IT WOULD NOT LOCK INTO PLACE AND COULD BE EASILY REMOVED WITH LITTLE EFFORTS. SURGEON THOUGHT THE THREADS ON THE SCREW WERE EITHER WARPED OR WORN. CASE WAS COMPLETED USING ANOTHER AR-8916VNC-18 FROM A DIFFERENT LOT NUMBER. THIS WAS DISCOVERED DURING DISTAL RADIUS FRACTURE PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED: 1/26/2022: THE IMPLANT DID NOT BREAK IN ANY FASHION AND ALL OTHER DEVICES WERE IMPLANTED SUCCESSFULLY EXHIBITING A STRONG REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567660 ↗
• InjuryDec 27, 2017Bent

  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 216861; AR-8916VNC-16, LOT: 95141729 / LINE 217127; AR-8916VNC-18, LOT: 95241731 / LINE 217128; AR-8935-12, LOT: 10150458 / LINE 217129; AR-8935-14, LOT: 10158950

  Patient problems: Failure of Implant

  MAUDE report 7147521 ↗