Arthrex® AR-8724V-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888867045613), received between Jan 9, 2020 and Dec 4, 2025 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Positioning Failure; Positioning Failure

  ON (B)(6) 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 23718979 ↗
• MalfunctionDec 4, 2025Positioning Failure; Positioning Failure

  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 A 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 23718694 ↗
• MalfunctionMay 16, 2024Unintended Movement; Unintended Movement

  ON 3/31/2022, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-8724V-18 LOW PROFILE VA LOCKING SCREW DID NOT LOCK INTO THE PLATE AND PASSED RIGHT THROUGH THE PLATE INTO THE BONE UNDER THE PLATE. SURGEON WAS ABLE TO REMOVE THE SCREW AND DID NOT HAVE TO REMOVE THE PLATE. THIS WAS DISCOVERED DURING A DISTAL RADIUS PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 19331801 ↗
• MalfunctionMar 7, 2024Failure to Advance; Failure to Advance

  ON 02/23/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8724V-20 LOW PROFILE VA LOCKING SCREW WENT THROUGH THE PLATE, AND (3) AR-8724V-18 LOW PROFILE VA LOCKING SCREWS WOULD NOT LOCK INTO THE PLATE. THIS OCCURRED DURING A DISTAL RADIUS PROCEDURE ON (B)(6) 2024, WHERE THE PLATE WAS STILL USED IN THE CASE HOWEVER, A SCREW WAS NOT PLACED IN THE AREA WHERE THE AR-8724V-20 WENT THROUGH. THE CASE WAS COMPLETED USING SCREWS FROM A MINI FRAG SET. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18859860 ↗
• MalfunctionMar 7, 2024Failure to Advance; Failure to Advance

  ON 02/23/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8724V-20 LOW PROFILE VA LOCKING SCREW WENT THROUGH THE PLATE, AND (3) AR-8724V-18 LOW PROFILE VA LOCKING SCREWS WOULD NOT LOCK INTO THE PLATE. THIS OCCURRED DURING A DISTAL RADIUS PROCEDURE ON (B)(6) 2024, WHERE THE PLATE WAS STILL USED IN THE CASE HOWEVER, A SCREW WAS NOT PLACED IN THE AREA WHERE THE AR-8724V-20 WENT THROUGH. THE CASE WAS COMPLETED USING SCREWS FROM A MINI FRAG SET. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18859620 ↗
• MalfunctionMar 7, 2024Failure to Advance; Failure to Advance

  ON 02/23/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8724V-20 LOW PROFILE VA LOCKING SCREW WENT THROUGH THE PLATE, AND (3) AR-8724V-18 LOW PROFILE VA LOCKING SCREWS WOULD NOT LOCK INTO THE PLATE. THIS OCCURRED DURING A DISTAL RADIUS PROCEDURE ON (B)(6) 2024, WHERE THE PLATE WAS STILL USED IN THE CASE HOWEVER, A SCREW WAS NOT PLACED IN THE AREA WHERE THE AR-8724V-20 WENT THROUGH. THE CASE WAS COMPLETED USING SCREWS FROM A MINI FRAG SET. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18859440 ↗
• 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 10460714 ↗
• 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 10460606 ↗
• InjuryJun 23, 2020Patient-Device Incompatibility; Appropriate Device Problem Term/Code Not Available

  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; No Code Available; Rash; Reaction

  MAUDE report 10184188 ↗
• InjuryJan 9, 2020Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SURGEON HAD TO REMOVE THE WRIST SPANNING PLATE, AR-8916SPN, BECAUSE THE SCREWS WERE BACKING OUT OF THE DISTAL HOLES. NO FURTHER INFORMATION, ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED (B)(6) 2019: CASE DATE OF IMPLANTATION: (B)(6) 2019. CASE DATE OF EXPLANTATION: NOT YET DETERMINED THE FOLLOWING SCREWS WERE ALSO EXPLANTED DURING THE REVISION: AR-8724-12 LOT: 2542021. AR-8724V-12 LOT: 2605841. AR-8724V-18 LOT: 2605831. AR-8935-14 LOT: 10176201. AR-8935-14 LOT:10249431. THE SPECIFIC DATE OF THE SECOND SURGERY (EXPLANT) IS UNKNOWN, HOWEVER IT IS KNOWN THAT THE DATE WAS PRIOR TO (B)(6) 2019. FOR REPORTING PURPOSES (B)(6) 2019 HAS BEEN ENTERED AS THE DATE OF EVENT.

  Patient problems: Failure of Implant

  MAUDE report 9569899 ↗