Arthrex® AR-8835L-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867047532), received between Feb 13, 2018 and Jun 5, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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 5, 2024Use of Device Problem; Use of Device Problem

  ON 09/20/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8835L-12 LO-PRO LOCKING SCREW (LINE #1) AND AR-8835L-16 LO PRO LOCKING SCREW (LINE #2), WOULD NOT LOCK INTO THE PLATE. THIS WAS DISCOVERED DURING USE IN A CLAVICLE FRACTURE ON (B)(6) 2021. THE CASE WAS COMPLETED BY SWAPPING OUT THE SCREWS.

  Patient problems: Insufficient Information

  MAUDE report 19468353 ↗
• MalfunctionFeb 22, 2021Material Fragmentation

  IT WAS REPORTED THAT DURING A DEX PROCEDURE, THE AR-8835L-12, SCREW ROLLED INTO THE LOCKING HEAD WITH PLATE AND COULD NOT BE USED. ALL FRAGMENTS WERE REMOVED AND THE CASE WAS COMPLETED BY USING ANOTHER AR-8835L-12 WITHOUT FURTHER ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 11358081 ↗
• InjuryFeb 13, 2018Adverse Event Without Identified Device or Use Problem

  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 - CC136109 LINE 220806) 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

  Patient problems: Pain

  MAUDE report 7266955 ↗