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

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867130920), received between Jun 9, 2020 and Oct 29, 2025 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 18, 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.

• MalfunctionOct 29, 2025Defective Device; Defective Device

  ON 10/17/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-8916VNR-03 VOLAR DISTAL RADIUS PLATE AND AN AR-8724VCL-20 KREULOCK¿ COMPRESSION SCREW FAILED. THIS OCCURRED DURING A DISTAL RADIUS FRACTURE ON (B)(6) 2025. AFTER PLACING THE SMALL 2.4 SCREWS INTO THE PLATE, THE SURGEON PROCEEDED TO INSERT THE AR-8724VCL-20 SCREW INTO THE PLATE, BUT THE SCREW WENT STRAIGHT THROUGH THE PLATE. THE SURGEON PROCEEDED TO REMOVE THE PLATE AND ALL THE SCREWS, INCLUDING THE ONE THAT WENT THROUGH THE PLATE. THE CASE CONTINUED USING ANOTHER AR-8916VNR-03 VOLAR DISTAL RADIUS PLATE AND ANOTHER AR-8724VCL-20 KREULOCK¿ COMPRESSION SCREW, ALONG WITH THE SAME 2.4 SCREWS THAT WERE FIRST ATTEMPTED. THE PATIENT'S BONE WAS PREPPED USING AN AR-8916-14 DRILL BIT. THERE WAS ABOUT A 10-MINUTE DELAY THAT DID NOT REQUIRE ADDITIONAL ANESTHESIA. THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS PROVIDED ON 10/17/2025 WHERE THE SALES REPRESENTATIVE REPORTED THAT THE PATIENT HAD GOOD BONE QUALITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23418105 ↗
• InjurySep 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT ENROLLED IN THE HAND AND WRIST REGISTRY HAD DEVELOPED CARPAL TUNNEL SYNDROME. THE PATIENT HAD PREVIOUSLY PRESENTED FOR FOLLOW-UP ON (B)(6) 2025, REPORTING PROGRESSIVE NUMBNESS IN THE THUMB, INDEX, AND LONG FINGERS FOLLOWING SURGERY. ULTRASOUND EVALUATION OF THE RIGHT CARPAL TUNNEL REVEALED FINDINGS CONSISTENT WITH CARPAL TUNNEL SYNDROME. TO ALLEVIATE SYMPTOMS, THE PATIENT UNDERWENT RIGHT CARPAL TUNNEL RELEASE SURGERY ON (B)(6) 2025. THIS EVENT WAS DETERMINED TO BE RELATED TO THE KREULOCK SCREW UTILIZED DURING THE DISTAL RADIUS FRACTURE FIXATION PROCEDURE PERFORMED ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 8/20/2025: DURING THE PROCEDURE ON (B)(6) 2025, THE PATIENT WAS IMPLANTED WITH AN AR-8724VCL-18 VAL KREULOCK SCREW, AN AR-8724VCL-16 VAL KREULOCK SCREW, AN AR-8724VCL-14 VAL KREULOCK SCREW, AN AR-8935-12 LOW PROFILE SCREW, AND AN AR-8916VNR-03 VOLAR DISTAL RADIUS PLATE. NO ARTHREX PRODUCTS WERE EXPLANTED OR IMPLANTED DURING THE RIGHT CARPAL TUNNEL RELEASE SURGERY ON (B)(6) 2025. THE SURGEON CONFIRMED THAT THE PATIENT'S CARPAL TUNNEL SYNDROME IS NOT RELATED TO THE ARTHREX PRODUCTS, AS MANY PA

  Patient problems: Numbness

  MAUDE report 23005436 ↗
• MalfunctionJun 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED ON 03/17/2023 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8916VNR-03 RADIAL PLATE HAD HEAD OF VNC SCREW PULL THROUGH THE PLATE. AR-8916VNC-20 AS THE SCREW ITEM NUMBER. CASE INVOLVEMENT, NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19497553 ↗
• MalfunctionJun 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 12/09/2021, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA E-MAIL THAT THERE WAS AN ISSUE WITH LOCKING SCREWS ENGAGING WITH THE AR-8916VNR-03 VOLAR PLATE. THIS OCCURRED DURING A DISTAL RADIUS SURGERY ON 12/08/2021 WHEN THE SURGEON TRIED USING THE VARIABLE ANGLE GUIDE TO INSERT (3) AR-8724V-22, (2) AR-8724V-2, AND (1) AR-8724V-16 SCREWS INTO THE AR-8916VNR-03 VOLAR PLATE . ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED ON 12/10/2021 : THE DEVICE WAS USED IN THE PROCEDURE, BUT WHEN IT WAS REALIZED THE SCREWS WERE NOT LOCKING INTO THE PLATE, A BACKUP PLATE AND SCREWS THAT WORKED PROPERLY WERE USED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19483227 ↗
• InjuryJun 23, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE PRODUCT TEAM THAT A SALES REP HAS REPORTED A POSSIBLE PATIENT REACTION INCIDENT INVOLVING AN ARTHREX VOLAR PLATE. THE MATERIAL COMPOSITION INFORMATION WAS PROVIDED TO THE SALES REP, FOR THE SURGEON, BY THE PRODUCT TEAM. ADDITIONAL INFORMATION PROVIDED 6/1/2020: THE PATIENT HAD UNDERGONE A DISTAL RADIUS FRACTURE ORIF PROCEDURE ON (B)(6) 2020. THE PATIENT HAD THE INITIAL POST OP VISIT ON (B)(6) 2020 AT WHICH TIME THE PATIENT WAS TAKEN TO THE OR FOR AND IRRIGATION AND DEBRIDEMENT FOR A PRESUMED INFECTION. CULTURES HAS ALL BEEN NEGATIVE: NEGATIVE AEROBIC, ANAEROBIC, FUNGAL AND AFB. SYMPTOMS OF DRAINAGE, BLISTERING, RASHES AND WOUND HEALING ISSUES HAVE ALL BEEN ASSESSED BY THE SURGEON, INFECTIOUS DISEASE AND DERMATOLOGY. PATIENT HAS BEEN TREATED TO DATE WITH STEROIDS AND ANTIBIOTICS (TOPICAL AND ORAL). IT IS UNKNOWN IF PATIENT HAS BEEN TESTED FOR SPECIFIC KNOWN ALLERGIES HOWEVER IT HAS BEEN REPORTED THAT PATIENT HAS DEVELOPED ALLERGIC REACTION TO ALMOST EVERYTHING (ADHESIVE, SUTURE, PREP, MULTIPLE ANTIBIOTICS). THE PATIENT HAS AN ALLERGIST VISIT SCHEDULED FOR (B)(6) 2020. THE FOLLOWING ARE THE ARTHREX DEVICES THAT WERE IMPLANTED DURING THE (B)(6) 2020 PROCEDU

  Patient problems: Impaired Healing; Rash; Reaction; Swelling

  MAUDE report 10184089 ↗
• InjuryJun 9, 2020Inadequacy of Device Shape and/or Size; Use of Device Problem

  AN ARTHREX SALES REP WAS NOT PRESENT DURING THE PROCEDURE. IT WAS REPORTED TO THE SALES REP THAT THE SURGEON WAS USING AN ARTHREX 5 HOLE STANDARD VOLAR PLATE (REP STATES THE PLATE WAS BELIEVED TO BE A RIGHT PLATE BASED ON THE X-RAY), AR-8916VSR-05, FROM A DRP SET. THE SET WAS A LOANER SET THAT HAD BEEN BROUGHT IN FOR A PREVIOUS CASE AND DUE TO COVID-19 IT WAS UNABLE TO BE RETRIEVED. THE SET WAS CALLED FOR AGAIN FOR THIS CASE. HE USED THE 1.7MM DRILL, AR-8916-14, THE DROP IN VAL GUIDE, AR-8916-21 (NOT AN EXTREME ANGLE), AND THEN PUT IN AN ARTHREX 2.4MM GOLD VAL LOCKING SCREW, AR-8724V-XX (LENGTH UNKNOWN), INTO ONE OF THE DISTAL HOLES OF THE PLATE. SURGEON REPORTED TO THE SALES REP THAT THE PROCEDURE WAS ALL BY THE BOOK. THE LOCKING SCREW WENT INTO THE HOLE AND HAD JUST A TINY BIT OF BITE AND THEN IT JUST SPUN IN THE PLATE HOLE. IT IS REPORTED TO THE SALES REP THAT OVER TENSIONING DID NOT OCCUR. SURGEON TRIED A LOCKING SCREW, 2.4MM VAL LOCKING SCREW, AR-8724V-XX (SIZE UNKNOWN), IN ANOTHER PLATE TO TEST FEEL WHAT IT SHOULD BE LIKE INTRA OP AND IT HAD GOOD BITE. AFTER THE FIRST LOCKING SCREW SPUN IN THE HOLE, THE SURGEON TRIED ANOTHER SCREW IN THE SAME HOLE WITH THE SAME RESULT. SURGEO

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 10133208 ↗