Arthrex® AR-8835L-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867047556), received between Jul 25, 2018 and Apr 3, 2025 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• 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 21764248 ↗
• 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 21764180 ↗
• MalfunctionJun 5, 2024Use of Device Problem; Use of Device Problem

  ON 09/20/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS 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 19468363 ↗
• InjuryFeb 16, 2024Break; Break

  ON 1/18/2024, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT AN AR-2685DR-10 DISTAL CLAVICLE PLATE BROKE EIGHT WEEKS POST-OPERATIVE. THE PATIENT UNDERWENT SURGERY ON (B)(6) 2023 FOR AN OPEN REDUCTION WITH INTERNAL FIXATION OF THE RIGHT COMMINUTED MID-SHIFT CLAVICLE FRACTURE. EIGHT WEEKS LATER, THE PATIENT RETURNED TO THE CLINIC, EXPERIENCING PAINFUL POPS IN THE SHOULDER. ON (B)(6) 2023, THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE AR-2685DR-10 DISTAL CLAVICLE PLATE. THE REVISION SURGERY WAS A REVISION OPEN REDUCTION AND INTERNAL FIXATION OF THE RIGHT CLAVICLE FRACTURE WITH ILIAC BONE GRAFT AND RIGHT CLAVICLE HARDWARE REMOVAL. NO FURTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 1/23/2024: DURING THE ORIGINAL PROCEDURE ON (B)(6) 2023, AN AR-2685DR-10 DISTAL CLAVICLE PLATE, AN AR-8827L-20 LOW PROFILE LOCKING SCREW, (4) AR-8827L-18 LOW PROFILE LOCKING SCREW, (2) AR-8835-16 LOW PROFILE SCREW, AN AR-8835-18 LOW PROFILE SCREW, (2) AR-8835L-18 LOW PROFILE LOCKING SCREW, AND AN AR-8835L-16 LOW PROFILE LOCKING SCREW WERE IMPLANTED. DURING THE REVISION SURGERY ON (B)(6) 2023, ALL THE IMPLANTS WERE SUCCESSFULLY REMOVED.

  Patient problems: Implant Pain

  MAUDE report 18723048 ↗
• InjuryMay 10, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE FOLLOWING DEVICES WERE IMPLANTED ON THE (B)(6) 2023: AR-2652CL (LOT: 5262102); AR-8835L-16 (LOT: 14975878); AR-8835L-18 (LOT: 14975879), AR-8835-16 (LOT: 14999011) AND AR-8835-18 (LOT: 14983034). THE PLATE BENT POST-OP WITHOUT EXTERNAL INFLUENCE. ON THE (B)(6) 2023 IT WAS REMOVED AND REPLACED WITH A NEW CLAVICLE FRACTURE PLATE (AR-2652CL). NO FURTHER INFORMATION RECEIVED.

  Patient problems: Failure of Implant

  MAUDE report 16904856 ↗
• InjuryMay 10, 2023Break; Break

  IT WAS REPORTED THAT THE FOLLOWING DEVICES WERE IMPLANTED ON THE (B)(6) 2022: AR-2651CL (LOT: 5262203); AR-8835-16 (ILOT: 14999011); AR-8835L-16 (LOT: 14975878) AND AR-8835L-18 (LOT: 14946776). THE PLATE BROKE POST-OP WITHOUT EXTERNAL INFLUENCE. ON THE (B)(6) 2023 IT WAS REMOVED AND REPLACED WITH A NEW CLAVICLE FRACTURE PLATE (AR-2652CL). NO FURTHER INFORMATION RECEIVED.

  Patient problems: Failure of Implant

  MAUDE report 16904811 ↗
• MalfunctionJun 13, 2022Break

  ON 5/24/2022, 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: ONEAR-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 14675201 ↗
• 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, AR-8926T / LOT: 17469 X1. PATIENT UNDERWENT A SECOND PROCEDURE ON (B)(6) 2019 FOR AN UNKNOWN REASON. ALL DEVICES LISTED ABOVE WERE EXPLANTED. ADDITIONAL INFORMATION PROVIDED 4/24/2019: 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 8526628 ↗
• InjuryJul 25, 2018Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ORIF OF LEFT CLAVICLE PROCEDURE ON (B)(6) 2018 WHERE AN AR-2652CL, LOT: UNK WAS IMPLANTED. ON (B)(6) 2018, AN INFECTION WAS NOTED ON HIS SKIN DURING HIS POST-OP VISIT. THE SURGEON ORDERED ANTIBIOTICS AND HAD CULTURES DONE. THE FACILITY IS CURRENTLY AWAITING THE RESULTS, HOWEVER, ACCORDING TO THE SURGEON, IT HAS COME BACK AS MRSA. A REVISION SURGERY HAS NOT BEEN SCHEDULED AND IT IS UNKNOWN IF ONE WILL BE. THE FOLLOWING DEVICES WERE ALSO IMPLANTED DURING THE ORIF OF LEFT CLAVICLE PROCEDURE: AR-8835-14 3.5 CORTICAL SCREW 14MM X1, AR-8835-16 3.5 CORTICAL SCREW 16MM X2, AR-8835L-16 3.5 LOCKING SCREW 16MMX 3.

  Patient problems: Bacterial Infection

  MAUDE report 7718936 ↗