Arthrex® AR-8935-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867050426), received between Jun 23, 2020 and Jun 4, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2024Positioning Failure; Positioning Failure

  ON 11/9/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8935-16 LOW PROFILE SCREW WENT RIGHT THROUGH AN AR-9943BR-06 LOCKING DISTAL FIBULA PLATE DURING INSERTION. THIS WAS DISCOVERED DURING AN ANKLE FRACTURE PROCEDURE ON (B)(6) 2022. SURGEON REMOVED THE SCREW AND INSERTED ANOTHER IN THE SAME AR-9943BR-06 LOCKING DISTAL FIBULA PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19463325 ↗
• InjuryJul 1, 2020Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DISTAL RADIUS ORIF PROCEDURE, UPON FINAL INSERTION OF THE AR-8935-16 (3.5 LOW PROFILE SCREW), THE HEAD OF THE SCREW BROKE OFF OF THE SCREW BODY. ALL OF THE SCREW BODY REMAINED IN THE PATIENT (APPROXIMATELY 16 MM). THIS OCCURRED DURING THE FINAL SEATING OF THE SCREW. THE SURGEON USED AND AR-8916-14, 1.7MM DRILL BIT TO PREP THE BONE SOCKET. THE PATIENT WAS REPORTED TO HAVE GOOD BONE QUALITY. PATIENT WAS A (B)(6) MALE. AFTER THE SCREW HEAD BROKE OFF AND THE SCREW BODY REMAINED, IT WAS REPORTED THAT THE TWO OTHER DISTAL 3.5 CORTICAL SCREWS HAD GOOD PURCHASE AND THE SURGEON WAS CONFIDENT ENOUGH IN THE CONSTRUCT TO PROCEED WITH THE CASE. THE CASE WAS COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10218064 ↗
• 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 (B)(6) 2020 PROCEDURE

  Patient problems: Impaired Healing; No Code Available; Rash; Reaction; Unspecified Infection

  MAUDE report 10184123 ↗