Arthrex® AR-2653CLRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00888867027442), received between Apr 12, 2017 and Mar 7, 2025 — classified as 10 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMar 7, 2025Break; Break

  IT WAS REPORTED THAT THE PLATE BROKE POST OPERATIVE. IT WAS FURTHER REPORTED THAT THE PATIENT PERFORMED STRENGTH TRAINING AND THAT THE PLATE PRESUMABLY BROKE DURING THE TRAINING. THE DEVICE WAS INITIALLY IMPLANTED ON (B)(6) 2025 AND WAS REMOVED ON (B)(6) 2025. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Failure of Implant

  MAUDE report 21545640 ↗
• MalfunctionFeb 21, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A PATIENT VIA PHONE THAT AN AR-2653CL CLAVICLE PLATE WAS EXPLANTED ON (B)(6) 2020 DUE TO AN X-RAY SHOWING THE DEVICE WAS BROKEN. THE AR-2653CL WAS ORIGINALLY IMPLANTED ON (B)(6) 2019. AN A NEW CLAVICLE PLATE WAS IMPLANTED DURING THE REPORTED REVISION SURGERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13569654 ↗
• InjuryAug 10, 2021Device Slipped; Output Problem

  THE FOLLOWING WAS FOUND DURING A MAUDE REVIEW: IT WAS REPORTED THAT A PATIENT HAD A MIDSHAFT CLAVICLE THAT WAS TREATED WITH AN ARTHREX CLAVICLE PLATE ON (B)(6) 2021. REDUCTION WAS AN ANATOMIC WITH NO CONCERNS LEAVING THE OPERATING ROOM. PATIENT RETURNED ON (B)(6) 2021 FOR FOLLOW UP AND THE HARDWARE HAD FAILED AND SCREWS WERE FREE FLOATING. THE PATIENT IS VERY HEALTHY AND COMPLIANT. ON (B)(6)2021 THE PLATE WAS REMOVED AND REPLACED WITH A SYNTHES CLAVICLE PLATE.

  Patient problems: Insufficient Information

  MAUDE report 12300586 ↗
• MalfunctionJun 11, 2021Break

  IT WAS REPORTED THAT AFTER AN INITIAL IMPLANTATION IN (B)(6) 2020 THE PLATE WAS FOUND TO BE BROKEN. THEREFORE A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 AND THE BROKEN PLATE WAS REPLACED WITH A NEW ONE WITH THE SAME PART NUMBER. IT WAS FURTHER REPORTED THAT THE BREAKAGE POINT OF THE PLATE WAS NOT AT THE BREAKAGE POINT OF THE BONE. THE PATIENT INITIALLY DID NOT REALIZED THAT THE PLATE WAS BROKEN.

  Patient problems: Failure of Implant

  MAUDE report 11981848 ↗
• MalfunctionMar 12, 2021Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH AR-2653CL PLATE. AFTER HEALING AND POSTOPERATIVE PHASE, WHEN THE PLATE WAS REMOVED, IT WAS FOUND THAT IT HAD BENT DURING HEALING. NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY WAS REPORTED. UPDATE 23-FEB-2021: THE REMOVAL OF THE PLATE WAS PLANNED. SURGEON NOTICED DURING THE HEALING PROCESS THAT THE PLATE HAD BENT. HOWEVER, THERE WERE NO HEALING PROBLEMS. SO THEY WAITED UNTIL EVERYTHING WAS HEALED, LEFT THE PLATE IN & REMOVED THE PLATE IN A TIMELY MANNER WHEN THE HEALING PROCESS WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11475085 ↗
• InjuryJan 5, 2021Break

  IT WAS REPORTED THAT THE AR-2653CL PLATE BROKE POST OP. THE ORIGINAL DATE OF SURGERY WAS (B)(6) 2020; CLAVICLE FRACTURE AND REVERSE TOTAL SHOULDER. PATIENT IS MALE, (B)(6); THERE WAS NO KNOWN EVENT THAT CAUSED THE BREAK. A SECOND SURGERY WAS DONE TO REMOVE THE BROKEN PLATE AND A SYNTHES PLATE WAS IMPLANTED.

  Patient problems: Bone Fracture(s)

  MAUDE report 11117171 ↗
• InjurySep 22, 2020Break

  IT WAS REPORTED THAT A CLAVICULA PLATE BROKE POST OP. THE PLATE WAS REMOVED DURING A REVISION SURGERY AND ANOTHER PLATE FROM ANOTHER MANUFACTURER WAS IMPLANTED. AT THE MOMENT, PART AND BATCH NUMBERS OF THE PLATE AND THE ASSOCIATED SCREWS ARE UNKNOWN. FURTHER MORE, THE DATE OF THE INITIAL SURGERY AND THE REVISION SURGERY ARE UNKNOWN. UPDATE 17-SEP-2020: FOLLOWING INFORMATION RECEIVED FROM PATIENT'S SOLICITOR: ALONG WITH THE PLATE THE FOLLOWING SCREWS WERE USED: 3X AR-8835-X (LENGTH UNKNOWN), AND 5X AR-8835L-X (LENGHT UNKNOWN). PATIENT IS MALE, SIZE 178 CM, (B)(6) KG, YOB: (B)(6), RETIRED. HE DID NOT RIDE BIKE, NOR DID HE MOVE HEAVY LOADS, NOR WAS HE PHYSICALLY ACTIVE. UPDATE 21-SEP-2020: FOLLOWING UPDATE RECEIVED: INITIAL SURGERY WAS PERFORMED ON (B)(6) 2020. REVISION SURGERY WAS PERFORMED ON (B)(6) 2020.

  Patient problems: Failure of Implant

  MAUDE report 10566981 ↗
• InjurySep 17, 2020Break

  IT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATIVE THAT THE PATIENT HAD AN ARTHREX AR-2653CL CLAVICLE PLATE (LOT 6791442) IMPLANTED. ON OR AROUND (B)(6) 2019 THE PATIENT NOTICED PAIN, REDNESS AND A LUMP INHER CLAVICLE. SHE PROCEEDED TO THE EMERGENCY ROOM WHERE X-RAYS WERE TAKEN DEMONSTRATING THE PLATE HAD BROKEN. THE PLATE WAS SUBSEQUENTLY SURGICALLY REMOVED ON OR AROUND (B)(6) 2019.

  Patient problems: Erythema; Pain; Swelling

  MAUDE report 10547374 ↗
• InjuryDec 26, 2019Break

  IT WAS PREVIOUSLY REPORTED THAT A PATIENT HAD A REVISION PROCEDURE ON (B)(6) 2019 DUE TO A BROKEN CLAVICLE PLATE (CASE (B)(4)). ON (B)(6) 2019 THE PATIENT STARTED EXPERIENCING PAIN AND DISCOMFORT, AND RECOGNIZED THAT THEIR CLAVICLE HAD MOVED AND THEIR SKIN WAS TENTING. THE PATIENT HAD A FOLLOW-UP VISIT WITH THEIR SURGEON ON (B)(6) 2019, AND THE X-RAYS TAKEN DURING THE FOLLOW-UP REVELED THE IMPLANTED HARDWARE HAD BROKEN. THE SECOND REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2019. COPIES OF X-RAYS WERE PROVIDED AND HAVE BEEN ATTACHED TO THE COMPLAINT RECORD. THE ARTHREX PART AND LOT NUMBERS THAT WERE EXPLANTED AND IMPLANTED DURING THE (B)(6) 2019 REVISION PROCEDURE ARE CURRENTLY UNKNOWN. ADDITIONAL INFORMATION RECEIVED ON 12/12/2019: THE REP PROVIDED THE PART NUMBERS OF THE ARTHREX PRODUCT USED AND IMPLANTED DURING THE (B)(6) 2019 REVISION PROCEDURE. THE REP REPORTED ALL IMPLANTED ARTHEX PRODUCT WAS EXPLANTED DURING THE SECOND REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2019. THE PART NUMBERS OF DEVICES IMPLANTED DURING THE (B)(6) 2019 PROCEDURE IS STILL UNKNOWN AT THIS TIME. THE FOLLOWING ARTHREX PRODUCTS WERE USED DURING THE REVISION 07/05/2019 PROCEDURE; AR-2653CL // LOT: 5261824

  Patient problems: Discomfort; Pain

  MAUDE report 9519555 ↗
• InjuryNov 6, 2019Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT HAD A PRIMARY CLAVICLE FRACTURE PROCEDURE ON (B)(6) 2019 IN WHICH AR-2653CL / LOT: 6791238 WAS IMPLANTED. ON (B)(6) 2019 THE PATIENT STARTED EXPERIENCING PAIN AND DISCOMFORT, AND HAD A FOLLOW-UP VISIT WITH THEIR SURGEON. X-RAYS WERE TAKEN DURING THE FOLLOW-UP VISIT, AND CONFIRMED THE IMPLANTED AR-2653CL HAD BENT. ON (B)(6) 2019 A REVISION PROCEDURE WAS PERFORMED BY THE SAME SURGEON AT A NEIGHBORING FACILITY. THE AR-2653CL ALONG WITH A TOTAL OF TEN SCREWS (PART AND LOT NUMBERS UNKNOWN) WERE REMOVED. THE PATIENT STATED THEY HAVE ALL EXPLANTED DEVICES IN THEIR POSSESSION. THE PATIENT BELIEVES THEY HAD ANOTHER AR-2653CL (LOT UNKNOWN) IMPLANTED DURING THE REVISION PROCEDURE, BUT THEY CANNOT CURRENTLY CONFIRM WHAT DEVICES WERE IMPLANTED DURING THE REVISION. ON (B)(6) 2019 THE PATIENT STARTED EXPERIENCING PAIN AND DISCOMFORT, AND RECOGNIZED THAT THEIR CLAVICLE HAD MOVED AND THEIR SKIN WAS TENTING. A THIRD PROCEDURE HAS NOT YET BEEN SCHEDULED, AND X-RAYS HAVE NOT BEEN TAKEN. THE PATIENT STATED THEY HAVE BEEN COMPLIANT, AND THEIR PAIN STARTED AFTER AND DURING REHABILITATION.

  Patient problems: Discomfort; Pain

  MAUDE report 9287048 ↗
• InjuryApr 18, 2018Break

  IT WAS INITIALLY REPORTED THAT REP WAS TOLD OF TWO CASES OF POST-OP CLAVICLE PLATE BREAKAGE AT 4-6 WEEKS POST OP. NO FURTHER DETAILS WERE AVAILABLE AT TIME OF INITIAL REPORT. FOLLOW-UP INVESTIGATION: PATIENT UNDERWENT AN ORIF CLAVICLE PROCEDURE ON (B)(6) 2018. FOUR WEEKS POST OP IT WAS DISCOVERED THAT THE AR-2653CL LOT 6791303 PLATE HAD BROKEN. IT WAS REPORTED TO THE SALES REP BY THE SURGEON THAT THE PATIENT DID NOT SUFFER ANY TRAUMA OR INJURY POST THE ORIGINAL SURGERY/PRIOR TO DISCOVERING THE BROKEN PLATE. A REVISION SURGERY HAS BEEN PERFORMED AT THE SAME FACILITY ON (B)(6) 2018. DURING THE REVISION THE BROKEN AR-2653CL WAS EXPLANTED ALONG WITH THE SCREWS. THE DEVICES WERE DISCARDED AFTER THE CASE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER MANUFACTURERS CLAVICLE PLATE. THE FOLLOWING SCREWS WERE ALSO EXPLANTED AT THE TIME OF REVISION: AR-8835-16 (QTY 4) LOT 031716, AR-8835-12 (QTY1) LOT 031724, AR-8835-18 (QTY 2) LOT W49116, AR-8835-14 (QTY 1) LOT 031724, AR-8835L-14 (QTY 2) LOT 031722, AR-8835L-16 (QTY 1) LOT W47694.

  Patient problems: No Code Available

  MAUDE report 7439299 ↗
• InjuryNov 15, 2017Break

  IT WAS REPORTED THAT THE PATIENT'S ORIGINAL SURGERY WAS (B)(6) 2017; WHEN HE RECENTLY PICKED UP HIS CHILD ((B)(6) LBS), HE FELT SOMETHING SNAP. THE PLATE HAD BROKEN. ON (B)(6) 2017, THERE WAS A SECOND SURGERY, THE PLATE WAS REMOVED AND ANOTHER MANUFACTURER'S PLATE WAS INSERTED. CALLER WAS NOT IN EITHER CASE, HAD NO FURTHER PATIENT INFO OR THE REASON FOR THE ORIGINAL CASE. THE BROKEN PLATE WAS DISCARDED. FOLLOW-UP INVESTIGATION: ORIGINAL IMPLANTATION SURGERY TOOK PLACE ON (B)(6) 2017, NOT (B)(6) 2017 AS INITIALLY REPORTED. FOLLOW-UP INVESTIGATION: THE CLAVICLE PLATE WAS PART NUMBER AR-2653CL, LOT 6791303. DURING THE (B)(6) 2017 PROCEDURE THE FOLLOWING SCREWS WERE ALSO EXPLANTED: AR-8835-12 LOT 95241630 QTY 1, AR-8835-16 LOT 95241717 QTY 1, AR-8835L-16 LOT F53610 QTY 4, AR-8835L-18 LOT 10034770 QTY 2, AR-2265-14H LOT 135138 QTY 1 AND AR-2665-16H LOT 135139 QTY 1.

  Patient problems: No Information

  MAUDE report 7033767 ↗
• InjuryApr 12, 2017Break

  IT WAS REPORTED THAT THE ORIGINAL PROCEDURE WAS ON (B)(6) 2017. PATIENT WAS COOKING ON (B)(6) 2017 AND FELT A SHARP PAIN WHEN HE REACHED FOR A POT. THOUGHT THE PLATE HAD BROKEN. IT WAS CONFIRMED THE FOLLOWING WEEK. PLATE WAS REMOVED ON (B)(6) 2017. CASE: LEFT CLAVICLE PATIENT: (B)(6) MALE. APPROXIMATELY (B)(6). ADDITIONAL INFORMATION OBTAINED 3/28/17: THE FOLLOWING SCREWS WERE ALSO EXPLANTED WHEN THE SURGEON EXPLANTED THE CLAVICLE FRACTURE PLATE: AR-8835L-20 (QTY 1), AR-8835L-18 (QTY 3), AR-8840-10 (QTY 2), AR-8835-08 (QTY 1), AR-8835L-16 (QTY 2), AR-8835-18 (QTY 1), AR-8835-22 (QTY 1). TO COMPLETE THE PROCEDURE THE SURGEON USED ANOTHER MANUFACTURER'S PRODUCT. THE PLATE BREAKAGE WAS MID-PLATE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 6484939 ↗