Arthrex® AR-8835-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867047310), received between Feb 13, 2018 and May 12, 2025 — classified as 2 injuries, 3 malfunctions.

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

• MalfunctionMay 12, 2025Use of Device Problem; Use of Device Problem

  ON 3/31/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A PATIENT'S CLAVICLE FRACTURE PLATE BROKE. NO FURTHER INFORMATION WAS PROVIDED. ON (B)(6) 2025, A PATIENT¿S LEGAL REPRESENTATIVE REPORTED VIA EMAIL THAT A CLAVICLE PLATE FRACTURED. THE PLATE WAS IMPLANTED DURING AN OPEN REDUCTION INTERNAL FIXATION OF THE RIGHT CLAVICLE PERFORMED ON (B)(6) 2024. ON (B)(6) 2024, IMAGING SHOWED A BENT CLAVICLE PLATE. ON (B)(6) 2024, IMAGING SHOWED A FRACTURED CLAVICLE PLATE. ON (B)(6) 2025, THE PATIENT UNDERWENT A PROCEDURE TO REMOVE THE HARDWARE. THE RECORDS INDICATED PATIENT NONCOMPLIANCE WITH POSTOPERATIVE PROTOCOL CONTRARY TO THE CLAVICLE PLATE'S DIRECTIONS FOR USE.

  Patient problems: Failure of Implant

  MAUDE report 22001609 ↗
• MalfunctionNov 6, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8835-20 LOW PROFILE SCREW HEAD BROKE OFF. THIS OCCURRED DURING AN ANKLE FRACTURE ON (B)(6) 2024 WHEN THE SCREW WAS INSERTED INTO THE BONE, THE SCREW HEAD BROKE OFF. THE FRAGMENT WAS ABLE TO BE RETRIEVED. THE PATIENT HAD AN AVERAGE BONE. A DRILL WAS USED TO PREP THE BONE. THIS RESULTED IN A DELAY OF 10-12 MINUTES. IT IS UNKNOWN IF ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE CASE WAS COMPLETED USING ANOTHER AR-8835-20. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20620077 ↗
• MalfunctionJun 13, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2652CR CLAVICLE FRACTURE PLATE WAS IMPLANTED IN PATIENT ON (B)(6) 2022 DURING A CLAVICLE FRACTURE. PATIENT FELT THE PLATE BREAK AND ON (B)(6) 2022, IT WAS CONFIRM VIA X-RAYS THAT THE PLATE HAD BROKEN. A REVISION SURGERY HAS BEEN SCHEDULE BY THE SAME SURGEON THAT PERFORMED THE ORIGINAL PROCEDURE AND IT WILL TAKE PLACE AT THE SAME FACILITY. THIS REVISION SURGERY HAS BEEN SCHEDULED FOR (B)(6) 2022 TO REMOVE ALL THE IMPLANTED SCREWS ALONG WITH THE BROKEN PLATE. ADDITIONAL INFORMATION RECEIVED ON 5/26/2022: DURING ORIGINAL PROCEDURE, SURGEON IMPLANTED THE FOLLOWING: ONE AR-2652CR CLAVICLE FRACTURE PLATE, ONE AR-2665-16H FRAGMENT SCREW, ONE AR-2665-18H FRAGMENT SCREW, ONE AR-2665-20H FRAGMENT SCREW, ONE AR-2665-22H FRAGMENT SCREW, ONE AR-8835-16 LOW PROFILE SCREW, ONE AR-8835-18 LOW PROFILE SCREW, TWO AR-8835-20 LOW PROFILE SCREWS, ONE AR-8835L-16 LOW PROFILE LOCKING SCREW, AND THREE AR-8835L-18 LOW PROFILE LOCKING SCREW. ALL THESE IMPLANTS WERE REMOVED DURING REVISION SURGERY ON (B)(6) 2022. CASE WAS COMPLETED SUCCESSFULLY USING SYNTHES WITHOUT FURTHER ISSUES.

  Patient problems: Failure of Implant

  MAUDE report 14675301 ↗
• InjuryApr 18, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017 THE PATIENT UNDERWENT AN ANKLE FRACTURE PROCEDURE WHERE THE FOLLOWING DEVICES WERE IMPLANTED: AR-8943C-10 / LOT: 1338539 X1, AR-8835-20 / LOT: 10016008 X1, AR-8835L-14 / LOT: 141751 X1, AR-8835L-16 / LOT: 10003529 X3, AR-8835L-18 / LOT: 1382955 X3, AND AR-8926T / LOT: 17469 X1. PATIENT UNDERWENT A SECOND PROCEDURE ON 01/8/2019 FOR AN UNKNOWN REASON. ALL DEVICES LISTED ABOVE WERE EXPLANTED. ADDITIONAL INFORMATION PROVIDED (B)(6) 2019: THE SECOND SURGERY WAS CONFIRMED AND THE DEVICES LISTED WERE EXPLANTED. PATIENT WAS OPERATED AND TITANIUM IMPLANTS WERE PLACED TO REPLACE THE EXPLANTED STEEL IMPLANTS. IT WAS REPORTED THAT THE PRODUCTS WERE WITHDRAWN IN THE SECOND SURGERY FOR SAFETY AND TO AVOID METALLOSIS. NO FURTHER EXPLANATION WAS PROVIDED AS TO ANY ADDITIONAL REASON FOR THE SECOND SURGERY.

  Patient problems: No Code Available

  MAUDE report 8526636 ↗
• InjuryFeb 13, 2018Insufficient Device Problem Information

  IT WAS REPORTED BY A FACILITY, WHO SENT A COPY OF A MEDWATCH (B)(4) WHICH THEY HAD FILED, THAT A PATIENT HAD ORIGINAL PLACEMENT OF HARDWARE THAT INCLUDED A PLATE AND SCREWS ON (B)(6) 2017 FOR A RIGHT DISPLACED LATERAL MALLEOLAR FRACTURE BY A HOSPITAL ORTHOPEDIC SURGEON. NO COMPLICATIONS WERE REPORTED. ON (B)(6) 2017 THE PATIENT WAS SEEN IN THE SURGEON'S OFFICE AND HAD COMPLAINTS OF INCREASING PAIN FOR THE PAST TWO MONTHS. THE PATIENT REPORTED TENDERNESS OVER PROMINENCE OF ONE OF THE SCREWS AS WELL AS THE ADDITIONAL AREA OF THE PLATE. THE SURGEON REVIEWED THE X-RAYS AND INDICATED NO CHANGE IN THE HARDWARE POSITION WITH NONE OF THE SCREWS BACKING OUT. ON (B)(6) 2017 THE PATIENT PRESENTED TO THE HOSPITAL WHERE THE ORTHOPEDIC SURGEON REPORTED THE FRACTURE AS HEALED BUT THE PATIENT REPORTED PAIN AND DYSFUNCTION WITH THE HARDWARE AND HAD WISHES FOR IT TO BE REMOVED. THE PATIENT HAD PLATE (AR-8943BR-04 LOCKING DISTAL FIBULA PLATE - (B)(4)) AND SCREW REMOVAL FROM HER RIGHT ANKLE UNDER GENERAL PLUS LOCAL ANESTHESIA. NO COMPLICATIONS WERE REPORTED FOLLOW-UP INVESTIGATION: PER FACILITY MEDWATCH REPORTER, THE SURGEON'S OFFICE NOTES INDICATED THAT THERE WAS PAIN AND "PROMINENCE AT LOCKING SCREW

  Patient problems: Pain

  MAUDE report 7266951 ↗