Arthrex® AR-8724V-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867045606), received between Jan 9, 2020 and Jun 3, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2024Fitting Problem; Fitting Problem

  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 (B)(6) 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: Insufficient Information

  MAUDE report 19453463 ↗
• MalfunctionMay 8, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A PROCEDURE THE SURGEON HAD AN ISSUE WITH A VOLAR DISTAL RADIUS PLATE. THE DISTAL 2.4 LOCKING SCREWS WOULD NOT LOCK INTO THE PLATE AND JUST SPUN IN PLACE. THE SURGEON THEN TOOK OUT THE PLATE, REPLACED WITH ANOTHER PLATE AND DID NOT WANT TO USE ANY OF THE SCREWS FROM THIS SET. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19269867 ↗
• 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 10460593 ↗
• 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 6/1/20: 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 3/3/20 PROCEDURE: AR-

  Patient problems: Impaired Healing; Rash; Reaction; Swelling

  MAUDE report 10184151 ↗
• InjuryJan 9, 2020Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SURGEON HAD TO REMOVE THE WRIST SPANNING PLATE, AR-8916SPN, BECAUSE THE SCREWS WERE NOT LOCKED INTO THE DISTAL HOLES. NO FURTHER INFORMATION, ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 12/18/2019: CASE DATE OF IMPLANTATION: (B)(6) 2019. CASE DATE OF EXPLANTATION: NOT YET DETERMINED. THE FOLLOWING SCREWS WERE ALSO EXPLANTED DURING THE REVISION: AR-8724-10 LOT: 1058931, AR-8724V-10 LOT: W654331, AR-8724V-16 LOT: W630941, AR-8935-12 LOT: 10220124, AR-8935L-12 LOT: 10248943, AR-8935L-12 LOT: 10257929. NOTE: 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: No Known Impact Or Consequence To Patient

  MAUDE report 9570046 ↗