Arthrex® AR-8835L-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867047549), received between Feb 13, 2018 and Mar 4, 2026 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2026Patient Device Interaction Problem

  ON 21-OCT-2025, A HEALTH CARE PROFESSIONAL REPORTED VIA EMAIL THAT A CLAVICLE PLATE IMPLANTED IN A PATIENT EXPERIENCED A FAILURE. ACCORDING TO THE REPORT, THE FAILURE OCCURRED APPROXIMATELY SIX MONTHS POST IMPLANTATION, AND NO TRAUMA WAS NOTED DURING THAT PERIOD. RADIOGRAPHIC IMAGES OF THE PLATE FAILURE WERE PROVIDED FOR REVIEW. ADDITIONAL INFORMATION WAS RECEIVED ON 24-OCT-2025: THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2025, INVOLVING AN ORIF OF THE RIGHT CLAVICLE. THERE WERE NO INTRAOPERATIVE COMPLICATIONS, INCLUDING NO CASE DELAYS, ADDED ANESTHESIA TIME, OR ADVERSE EVENTS. THE SPECIFIC ARTHREX PART NUMBERS USED DURING THE PROCEDURE WERE NOT PROVIDED. THE IMPLANT FAILURE WAS IDENTIFIED SIX MONTHS POSTOPERATIVELY, OCCURRING AT THE JUNCTION BETWEEN THE SCREW HOLES. A REVISION SURGERY HAS BEEN SCHEDULED. NO ADDITIONAL INFORMATION REGARDING THE EVENT IS AVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED ON 10/30/2025: THE SPECIFIC ARTHREX PART NUMBERS USED DURING THE INITIAL PROCEDURE HAVE NOT BEEN PROVIDED AT THIS TIME. A REVISION SURGERY IS SCHEDULED TO TAKE PLACE IN TWO WEEKS. THE PATIENT DID NOT REPORT ANY PRIOR SYMPTOMS OR EXPERIENCE A POPPING SENSATION AT THE SITE.

  Patient problems: Insufficient Information

  MAUDE report 24512118 ↗
• InjuryApr 3, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ISSUES OCCURRED AFTER THE IMPLANTATION OF AN CLAVICLE FRACTURE PLATE WITH MULTIPLE SCREWS IN (B)(6) 2024. SINCE THE IMPLANTATION THE PATIENT SUFFERS FROM PERSISTENT SYMPTOMS AND POSSIBLY INFLAMMATORY REACTIONS, THE CAUSE OF WHICH IS STILL UNCLEAR. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21764252 ↗
• InjuryApr 3, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ISSUES OCCURRED AFTER THE IMPLANTATION OF AN CLAVICLE FRACTURE PLATE WITH MULTIPLE SCREWS IN (B)(6) 2024. SINCE THE IMPLANTATION THE PATIENT SUFFERS FROM PERSISTENT SYMPTOMS AND POSSIBLY INFLAMMATORY REACTIONS, THE CAUSE OF WHICH IS STILL UNCLEAR. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21764226 ↗
• MalfunctionMay 24, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE DEVICE HAS LOOSENED IN THE CLAVICLE PLATE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THIS WAS NOTICED AFTER THE SURGERY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19397141 ↗
• MalfunctionMay 23, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE DEVICE HAS LOOSENED IN THE CLAVICLE PLATE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THIS WAS NOTICED AFTER THE SURGERY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Failure of Implant

  MAUDE report 19380533 ↗
• MalfunctionMay 13, 2024Use of Device Problem; Use of Device Problem

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT DURING A CLAVICLE FRACTURE, THE SCREW COULD NOT LOCK INTO PLATE. ANOTHER OF THE SAME WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 19298192 ↗
• InjuryAug 4, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE SCREW HAS LOOSENED IN THE CLAVICLE PLATE. NO FURTHER INFORMATION RECEIVED. 27-JUN-2023 UPDATE DW FURTHER INFORMATION WERE PROVIDED THAT THE FOLLOWING DEVICES BECAME LOOSE POST OP. AR-2652CL BATCH: 5262102 AR-8835L-14 BATCH: 15040867 AR-8835-14 BATCH: 10694746 2X AR-8835-16 BATCH: 1072011 3X AR-8835-18 BATCH: 10591283 AR-8827-14 BATCH: 1074240 AS THE REPORTED DEVICES ARE AVAILABLE FOR RETURN A REVISION SURGERY HAD TO BE PERFORMED BUT NO FURTHER INFORMATION WERE PROVIDED WHEN THE REVISION SURGERY WAS PERFORMED. 13-JUL-2023 UPDATE DW FURTHER INFORMATION WERE PROVIDED THAT A REVISION SURGERY WAS PERFORMED WITH A DEVICE FROM ANOTHER MANUFACTURER.

  Patient problems: Failure of Implant

  MAUDE report 17465826 ↗
• InjuryApr 18, 2019Appropriate Device Problem Term/Code Not Available

  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, AR-8926T / LOT: 17469 X1. PATIENT UNDERWENT A SECOND PROCEDURE ON (B)(6) 2019 FOR AN UNKNOWN REASON. ALL DEVICES LISTED ABOVE WERE EXPLANTED.

  Patient problems: No Information

  MAUDE report 8526629 ↗
• 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 7266958 ↗