Arthrex® AR-8916VNL-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867130852), received between Sep 19, 2018 and Dec 4, 2025 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (3 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Use of Device Problem; Use of Device Problem

  ON 11/17/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-8916VNL-03 VOLAR DISTAL RADIUS PLATE AND AN AR-8724V-20 LOCKING SCREW FAILED DURING A VOLAR DISTAL RADIUS ORIF PROCEDURE ON (B)(6) 2025. WHILE INSERTING THE SCREW INTO THE MOST DISTAL HOLES OF THE PLATE USING AN AR-8916TL-011 TORQUE LIMITER, THE SCREW DID NOT LOCK INTO THE PLATE AND PASSED STRAIGHT THROUGH. THE PLATE AND SCREW WERE REMOVED FROM THE PATIENT, AND THE CASE WAS COMPLETED USING A REPLACEMENT AR-8916VNL-03 PLATE AND ANOTHER LOW-PROFILE VA LOCKING SCREW. THE PATIENT HAD SOFTER BONE, WHICH HAD BEEN PREPARED USING AN ELEVATOR. THE CASE WAS DELAYED APPROXIMATELY 5¿10 MINUTES, REQUIRING ADDITIONAL ANESTHESIA. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23719606 ↗
• MalfunctionDec 4, 2025Positioning Failure; Use of Device Problem; Positioning Failure; Use of Device Problem

  ON 11/17/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-8916VNL-03 VOLAR DISTAL RADIUS PLATE AND TWO AR-8724V-18 LOW PROFILE VA LOCKING SCREWS FAILED DURING A VOLAR DISTAL RADIUS ORIF PROCEDURE ON (B)(6) 2025. WHILE INSERTING THE SCREWS INTO THE TWO MOST DISTAL HOLES OF THE PLATE USING AN AR-8916TL-011 TORQUE LIMITER, THE SCREWS DID NOT LOCK INTO THE PLATE AND PASSED STRAIGHT THROUGH. THE PLATE AND SCREWS WERE REMOVED FROM THE PATIENT, AND THE CASE WAS COMPLETED USING A REPLACEMENT AR-8916VNL-03 PLATE AND TWO NEW LOW PROFILE VA LOCKING SCREWS. THE PATIENT HAD SOFTER BONE, WHICH HAD BEEN PREPARED USING AN ELEVATOR. THE CASE WAS DELAYED APPROXIMATELY 5¿10 MINUTES, REQUIRING ADDITIONAL ANESTHESIA. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23718458 ↗
• 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 22481782 ↗
• InjuryOct 19, 2020Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT BEGAN EXPERIENCING SEVERE ECZEMA ON THE BACK OF THEIR NECK SHORTLY AFTER HAVING AR-8916VNL-03 VOLAR DISTAL RADIUS PLATE IMPLANTED. ECZEMA IS UNRESPONSIVE TO ALL TREATMENT. THE PHYSICIAN WILL BE TESTING FOR HEAVY METAL SENSITIVITY TO DETERMINE IF THERE IS ANY CORRELATION TO THE IMPLANT. ADDITIONAL INFORMATION OBTAINED 10/14/2020: THE DATE OF THE PATIENT'S IMPLANT SURGERY WAS (B)(6) 2018. PATIENT SYMPTOMS SINCE IMPLANT HAVE BEEN ECZEMA, SEVERE GLUTEN INTOLERANCE AND LEAKY GUT SYNDROME. SYMPTOMS BEGAN APPROXIMATELY 4 WEEKS POST SURGERY. TO DATE PATIENT HAS BEEN TREATED WITH A GLUTEN FREE DIET, ENZYME AND SUPPLEMENT THERAPY. NO CULTURES HAVE BEEN TAKEN. AT THIS TIME NO SECOND SURGERY IS PLANNED.

  Patient problems: Hypersensitivity/Allergic reaction; Rash

  MAUDE report 10698288 ↗
• InjuryAug 27, 2020Break

  IT WAS REPORTED THAT A PATIENT HAD UNDERGONE A PROCEDURE (B)(6) 2020. THE FIRST WEEK OF (B)(6) 2020 THE PATIENT HAD A FOLLOW UP VISIT AT THE SURGEON'S OFFICE AND X-RAYS TAKEN DURING THE FOLLOW UP SHOWED A FOREIGN BODY IS PRESENT. THE ITEM HAD NOT BEEN SEEN ON THE INTRAOPERATIVE X-RAYS TAKEN AT THE TIME OF PROCEDURE. IT WAS ALSO REPORTED THAT THE FOREIGN BODY IS NOT CAUSING ANY PAIN OR DISCOMFORT TO THE PATIENT. SURGEON BELIEVES THAT THE FOREIGN BODY MAY BE A THIN SHAVING FROM THE NARROW ULNAR PLATE/PLATE SCREWS THAT HAD BEEN IMPLANTED. SURGEON ALSO INDICATED THAT HE HAS SEEN THIS OCCUR PREVIOUSLY WITH THE ARTHREX SYSTEM THAT WAS USED. (INFORMATION HAS BEEN REQUESTED REGARDING THESE INSTANCES.) THE SHAVING WAS NOT NOTICED AT THE TIME OF OCCURRENCE TO DETERMINE THE SPECIFIC PRODUCT THE SHAVING MAY HAVE COME FROM. AT THIS TIME THE SURGEON DOES NOT HAVE PLANS TO REMOVE THE HARDWARE OR FOREIGN BODY BUT THE SALES REPRESENTATIVE HAS REQUESTED THAT THE SURGEON NOTIFY HIM IF A SECOND SURGERY IS SCHEDULED. THE FOLLOWING ARE THE PLATE AND SCREWS THAT WERE USED DURING THE (B)(6) 2020 PROCEDURE: AR-8916VNL-03, VOLAR DISTAL RADIUS PLATE, LOT 10440051. AR-8724-18, LOW PROFILE SCREW, LOT W652321.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10460569 ↗
• InjurySep 19, 2018Appropriate Device Problem Term/Code Not Available

  DURING SOCIAL SAFEGUARD CYBER REVIEW (ARTHREX CHATTER COMMUNITY) A POTENTIAL DEVICE ISSUE WAS DISCOVERED. UPON FURTHER INVESTIGATION IT WAS CONFIRMED ON (B)(6) 2018 THAT A REVISION PROCEDURE HAD TAKEN PLACE. ADDITIONAL INFORMATION WAS REQUESTED. ADDITIONAL INFORMATION OBTAINED 9/5/2018: A PATIENT HAD A DISTAL RADIUS FRACTURE PROCEDURE ON (B)(6) 2018. DURING THE PROCEDURE THE FOLLOWING DEVICES WERE IMPLANTED: AR-8916VNL-03, LOT: 10183688 (QTY 1), AR-8724V-20 (QTY 4, LOT: UNKNOWN), AR-8935L12 (QTY 1 LOT UNKNOWN), AR-8935L-14 (QTY 1 LOT UNKNOWN), AND AR-8935-12 (QTY1, LOT: UNKNOWN). THE PATIENT SUFFERED A FALL AND HAD A REVISION PROCEDURE ON (B)(6) 2018. DURING THE REVISION PROCEDURE ALL OF THE ORIGINAL IMPLANTS WERE REMOVED AND REPLACED. THE FOLLOWING DEVICES WERE IMPLANTED TO COMPLETE THE PROCEDURE: AR-8916VNL-03, LOT: 10189728 (QTY1), AR-8724V-18 (QTY1, LOT: UNKNOWN), AR-8724V-22 (QTY 3, LOT: UNKNOWN), AR-8935L-12 (QTY1, LOT: UNKNOWN), AR-8935L-14 (QTY 1, LOT: UNKNOWN), AND AR-8935-12 (QTY1, LOT: UNKNOWN). PER REPORTER IT IS UNKNOWN WHEN THE PATIENTS PAIN BEGAN OR IF PATIENT HAD ANY OTHER SYMPTOMS PRIOR TO THE PATIENT'S FALL. NO CULTURES WERE TAKEN OR ANY OTHER PROBLEMS FOUND DURIN

  Patient problems: Fall; Pain

  MAUDE report 7890070 ↗