Arthrex® AR-8835-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00888867047303), received between Feb 21, 2018 and Aug 8, 2025 — classified as 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2025Break; Break

  IT WAS REPORTED THAT DURING A CLAVICLE FRACTURE SURGERY THE PLATE BROKE IN THE MIDDLE DURING FASTENING. THE BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22750447 ↗
• MalfunctionAug 8, 2025Break; Break

  IT WAS REPORTED THAT DURING A CLAVICLE FRACTURE SURGERY THE PLATE BROKE IN THE MIDDLE DURING FASTENING. THE BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22750445 ↗
• 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 18723038 ↗
• MalfunctionNov 20, 2023Break; Break

  ON 10/27/2023, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT AN AR-8835-18 LOW PROFILE SCREW HEAD BROKE OFF DURING INSERTION. THE BODY OF THE SCREW WAS LEFT IMPLANTED AND THE HEAD WAS REMOVED. THIS WAS DISCOVERED DURING AN ORIF OF THE RIGHT CLAVICLE PROCEDURE ON 9/13/2023. NO FURTHER INFORMATION WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18175227 ↗
• MalfunctionOct 10, 2023Break; Break

  ON 9/13/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8835-18 LOW PROFILE SCREW HAD AN ISSUE. DURING A CLAVICLE FRACTURE PROCEDURE ON (B)(6) 2023, WHEN THE SURGEON WAS TRYING TO IMPLANT THE SCREW, THE HEAD OF THE SCREW BROKE OFF INSIDE THE PATIENT. THE HEAD OF THE SCREW WAS REMOVED, BUT THE REST OF THE SCREW REMAINED INSIDE THE CLAVICLE AS IT WAS SEATED FLUSH WITH THE PLATE. THE MAJORITY OF THE SCREWS WERE ALREADY SUCCESSFULLY IMPLANTED, SO THE LAST SCREW REMAINED INSIDE THE BONE AND WAS NOT REMOVED. THE SURGEON DEEMED IT SECURELY AFFIXED. THIS CAUSED A CASE DELAY OF OVER 15 MINUTES, AND IT COULD NOT BE CONFIRMED IF ADDITIONAL ANESTHESIA HAD TO BE ADMINISTERED. THE SURGEON WAS CONCERNED THAT THE PATIENT MIGHT WANT THE HARDWARE REMOVED IN THE FUTURE AND THAT THERE MIGHT BE COMPLICATIONS AS THE SCREW WAS AFFIXED TO THE PLATE. THE CLAVICLE FRACTURE PROCEDURE WAS COMPLETED SUCCESSFULLY, THERE WAS NO ADVERSE EFFECT OR HARM REPORTED. THE BROKEN SCREW FRAGMENT WAS DISCARDED, BUT A PICTURE WILL BE PROVIDED VIA EMAIL.

  Patient problems: Failure of Implant; Foreign Body In Patient

  MAUDE report 17908545 ↗
• InjuryJul 14, 2023Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Device Dislodged or Dislocated; 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.

  Patient problems: Failure of Implant

  MAUDE report 17326453 ↗
• 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 16904817 ↗
• 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 14675084 ↗
• InjuryJun 2, 2020Break

  IT WAS REPORTED THAT A PATIENT HAD A PRIMARY ORIF ANKLE FX PERFORMED ON (B)(6) 2019, AND WAS WALKING AT 10 WEEKS. WITHOUT EXPERIENCING A NEW INJURY, THE IMPLANTED ARTHREX PLATE BROKE AND DISPLACED THE FX. THE PATIENT WILL NEED A SECOND SURGERY. THERE WAS NOT AN ARTHREX SALES REPRESENTATIVE PRESENT DURING THE INITIAL CASE. 10 WEEK X-RAYS REVEALING THE BROKEN PLATE HAVE BEEN PROVIDED TO ARTHREX. ADDITIONAL INFORMATION RECEIVED ON 03/20/2020: THE REP PROVIDED THE ORIGINAL SALES ORDER FROM THE PRIMARY PROCEDURE. THE FOLLOWING ARTHREX DEVICES WERE IMPLANTED DURING THE PRIMARY SURGERY; AR-8943T-10 // LOT: 474735 X 1. AR-8835-14 // LOT: 10266334 X 1. AR-8835-14 // LOT: 10268858 X 1. AR-8835-14 // LOT: 10273289 X 1. AR-8835-14 // LOT: 10291574 X 1. AR-8835-16 // LOT: 10221152 X 1. AR-8835-18 // LOT: 10211116 X 1. AR-8835-18 // LOT: 10223067 X 1. AR-8840-14 // LOT: 10035722 X 1. AT TIME OF INITIAL REPORT TO ARTHREX (B)(6) 2020) OR WHEN THE ADDITIONAL INFORMATION WAS PROVIDED, ON (B)(6) 2020, THE SALES REP DID NOT HAVE ANY ADDITIONAL DETAILS PERTAINING TO THE EXPECTED SECOND SURGERY. ADDITIONAL INFORMATION OBTAINED 5/13/20: THERE WAS A DELAY IN OBTAINING INFORMATION DUE TO THE COVID-19 PANDE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10108730 ↗
• InjuryJun 2, 2020Break

  IT WAS REPORTED THAT A PATIENT HAD A PRIMARY ORIF ANKLE FX PERFORMED ON (B)(6) 2019, AND WAS WALKING AT 10 WEEKS. WITHOUT EXPERIENCING A NEW INJURY, THE IMPLANTED ARTHREX PLATE BROKE AND DISPLACED THE FX. THE PATIENT WILL NEED A SECOND SURGERY. THERE WAS NOT AN ARTHREX SALES REPRESENTATIVE PRESENT DURING THE INITIAL CASE. 10 WEEK X-RAYS REVEALING THE BROKEN PLATE HAVE BEEN PROVIDED TO ARTHREX. ADDITIONAL INFORMATION RECEIVED ON 03/20/2020: THE REP PROVIDED THE ORIGINAL SALES ORDER FROM THE PRIMARY PROCEDURE. THE FOLLOWING ARTHREX DEVICES WERE IMPLANTED DURING THE PRIMARY SURGERY; AR-8943T-10 // LOT: 474735 X 1, AR-8835-14 // LOT: 10266334 X 1, AR-8835-14 // LOT: 10268858 X 1, AR-8835-14 // LOT: 10273289 X 1, AR-8835-14 // LOT: 10291574 X 1, AR-8835-16 // LOT: 10221152 X 1, AR-8835-18 // LOT: 10211116 X 1, AR-8835-18 // LOT: 10223067 X 1, AR-8840-14 // LOT: 10035722 X 1. AT TIME OF INITIAL REPORT TO ARTHREX (MARCH 9-2020) OR WHEN THE ADDITIONAL INFORMATION WAS PROVIDED, ON MARCH 20-2020, THE SALES REP DID NOT HAVE ANY ADDITIONAL DETAILS PERTAINING TO THE EXPECTED SECOND SURGERY. ADDITIONAL INFORMATION OBTAINED 5/13/2020: THERE WAS A DELAY IN OBTAINING INFORMATION DUE TO THE COVID-19

  Patient problems: No Code Available

  MAUDE report 10108671 ↗
• InjuryFeb 21, 2018Break

  IT WAS REPORTED BY A DERMATOLOGIST'S OFFICE THAT A PATIENT IS CONCERNED HE IS ALLERGIC TO A COMPONENT OF THE PLATE AND SCREWS USED TO FIX HIS ANKLE IN 2015 AFTER HE SUFFERED A BREAK. REPORTER HAS REQUESTED MATERIAL COMPOSITION OF THE DEVICES. THE FOLLOWING ARE THE IMPLANTED DEVICES: AR-8943TH-05, LOCKING LATERAL HOOK PLATE, STAINLESS STEEL ((B)(4)). AR-8835-30, LOW PROFILE CORTICAL SCREW, STAINLESS STEEL ((B)(4)). AR-8835-18, LOW PROFILE CORTICAL SCREW, STAINLESS STEEL ((B)(4)). AR-8835-14, LOW PROFILE CORTICAL SCREW, STAINLESS STEEL ((B)(4)). AR-8840-14, LOW PROFILE CANCELLOUS SCREW, STAINLESS STEEL ((B)(4)). AR-8926SS, KNOTLESS TIGHTROPE SYNDESMOSIS REPAIR IMPLANT. FOLLOW-UP INVESTIGATION: PATIENT'S ORIGINAL SURGERY WAS IN (B)(6) 2014 (NOT 2015 AS ORIGINALLY REPORTED). SPECIFIC DATE IS UNKNOWN. SURGERY WAS AN ORIF OF THE LEFT ANKLE. PATIENT IS A MALE WITH KNOWN ALLERGY TO AMOXICILLIN. PATIENT HAS BEEN EXPERIENCING CHRONIC FATIGUE AND SLEEPINESS, ANXIETY AND PALPITATIONS AND BRADYCARDIA. TREATMENTS TO DATE ARE UNKNOWN. MATERIAL COMPOSITION OF THE IMPLANTED DEVICES HAS BEEN PROVIDED THE REPORTER. DEVICES ARE STAINLESS STEEL. SINCE A SPECIFIC DAY FOR THE ORIGINAL (B)(6) 2014 SURGERY

  Patient problems: Anxiety; Bradycardia; Fatigue; Hypersensitivity/Allergic reaction; Palpitations

  MAUDE report 7285140 ↗