Arthrex® AR-8935L-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867050853), received between Sep 19, 2018 and Mar 7, 2025 — classified as 5 injuries, 2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2025Positioning Failure; Positioning Failure

  ON 02/11/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN PLANTAR LAPIDUS SHORT PLATE WAS NOT ALLOWING SCREW TO LOCK IN. THIS OCCURRED DURING A LAPIDUS ARTHRODESIS ON (B)(6) 2025, WHEN THE AR-8935L-14 AND AN AR-8935L-18 SCREWS WERE NOT LOCKING INTO THE PLATE. EVERYTHING WAS REMOVED FROM THE PATIENT AND THEY PROCEEDED TO USE A NEW PLATE THAT WORKED. THE AR-8935L-18 SCREW WORKED WITH THE NEW PLATE; THE AR-8935L-14 WAS NOT USED.

  Patient problems: Insufficient Information

  MAUDE report 21545869 ↗
• MalfunctionJun 7, 2024Mechanical Jam; Mechanical Jam

  ON 5/18/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8935L-14 LOW PROFILE LOCKING SCREW WOULD NOT LOCK AND OR ENGAGE WITH THE PLATE. ANOTHER SCREW WAS USED AND CASE WAS COMPLETED WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING A DISTAL RADIUS FX PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19491191 ↗
• InjuryNov 2, 2020Device Dislodged or Dislocated

  THIS IS AN INITIAL REPORT TO RESUBMIT ALL PRIOR INFORMATION THAT WAS SUBMITTED THROUGH ARTHREX SUBMISSION THE INITIAL REPORTS DROPPED FROM THE FDA SYSTEM AND THEREFORE BLOCKED THE FULL PROCESSING OF A FOLLOW UP SUBMISSION. THE 2 SUBMISSIONS WENT THROUGH BUT ONLY THE RECEIPT AND 1 ACKNOWLEDGEMENT WITH NO CORE ID WERE RECEIVED. AFTER SEVERAL MONTHS OF INVESTIGATION WITH THE FDA, DUE TO COMPUTER SYSTEM CHANGES AT ARTHREX AS WELL AS THE FDA, THE FDA HAS AGREED THAT ARTHREX SHOULD RESUBMIT A NEW REPORT TO ENCOMPASS THE INITIAL PRIOR 2017 ARTHREX SUBMISSIONS INVOLVED. THIS REPORT IS IN REFERENCE TO: 1220246-2017-00332 (ARTHREX REFERENCE: (B)(4)/ LINE 204830). THE FOLLOWING IS THE PREVIOUSLY REPORTED INFORMATION MENTIONED ABOVE: IT WAS ORIGINALLY REPORTED THAT THE SCREWS BEGAN TO CHANGE ANGLE AFTER BEING IMPLANTED. ADDITIONAL INFORMATION RECEIVED ON 8/24/2017: IT WAS REPORTED THAT THE PATIENT UNDERWENT DISTAL RADIUS REPAIR ON (B)(6) 2017. ON (B)(6) 2017, THE PATIENT WAS EXPERIENCING PAIN AND DISPLACEMENT. THE VOLAR DISTAL RADIUS PLATE ALONG WITH ALL THE SCREWS WERE REMOVED ON (B)(6) 2017. ADDITIONAL INFORMATION RECEIVED 8/31/2017: THE ISSUE WAS FOUND DURING ROUTINE FOLLOW UP WITH X-RAYS.

  Patient problems: Pain

  MAUDE report 10774432 ↗
• 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 6/1/20: 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; Unspecified Infection

  MAUDE report 10184193 ↗
• InjuryJan 7, 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 12/18/19: CASE DATE OF IMPLANTATION: (B)(6) 2019, CASE DATE OF EXPLANTATION: (B)(6) 2019. THE FOLLOWING SCREWS WERE ALSO EXPLANTED DURING THE REVISION: AR-8916SPN LOT: 105641930, AR-8724-10 LOT: W646301, AR-8724V-10 LOT: 2610171, AR-8724V-12 LOT: W657601, AR-8935-14 LOT: 10279504, AR-8935L-12 LOT: 10257929, AR-8935L-14 LOT: 10277889.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9557240 ↗
• InjuryFeb 7, 2019Break

  IT WAS REPORTED THAT THE DRIVER TIP BROKE OFF IN THE SCREW DURING REMOVAL OF A LAPIDUS PLATE. ADDITIONAL INFORMATION OBTAINED (B)(6) 2019: THE PATIENT¿S ORIGINAL IMPLANT CASE WAS A LAPIDUS PROCEDURE. THE EXPLANT PROCEDURE, WHICH WAS A REMOVAL OF A LAPIDUS PLATE AND SCREWS, TOOK PLACE ON (B)(6) 2019. DEVICES WERE BEING EXPLANTED DUE TO PATIENT PAIN. DATE OF ORIGINAL LAPIDUS SURGERY HAS NOT BEEN PROVIDED AT THIS TIME. THE FOLLOWING DEVICES WERE EXPLANTED DURING THE (B)(6) 2019 PROCEDURE: AR-8941 LAPIDUS PLATE (QTY 1); AR-8935L-14 LOCKING SCREW, (QTY 1); AR-8935L-16 LOCKING SCREW (QTY 2); AND AR-8935-16 CORTICAL SCREW (QTY1). AFTER THE DRIVER TIP BROKE THE SURGEON CHOSE TO NOT EXPLANT THE 4.0 HEADLESS SCREW AND IT REMAINS IN THE PATIENT¿S BODY. NO FRAGMENTS OF THE BROKEN DRIVER WERE LEFT IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; Pain

  MAUDE report 8317055 ↗
• 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 DURING REVISION SURGERY

  Patient problems: Fall; Pain

  MAUDE report 7890130 ↗