Arthrex® AR-2653CRRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00888867027459), received between Jun 2, 2017 and May 15, 2026 — classified as 10 injuries, 2 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2026Break

  IT WAS REPORTED THAT A PATIENT¿S CLAVICLE PLATE HAD FRACTURED WHILE THE PATIENT WAS SLEEPING A FEW DAYS AFTER SURGERY. A REVISION SURGERY WAS PERFORMED BY THE SAME SURGEON AT THE SAME HOSPITAL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 25184339 ↗
• MalfunctionMar 5, 2026Break

  ON 11-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-2653CR CLAVICLE FRACTURE PLATE, WHICH HAD BEEN IMPLANTED DURING A PROCEDURE ON (B)(6) 2025, WAS FOUND TO BE BROKEN. NO ADDITIONAL CLINICAL DETAILS OR INFORMATION REGARDING WHEN OR HOW THE ISSUE WAS IDENTIFIED WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24518103 ↗
• InjuryMar 2, 2026Fracture

  IT WAS REPORTED THAT ON (B)(6) 2025, THE IMPLANTED PLATE FRACTURED WHEN THE PATIENT BENT FORWARD WITH HER UPPER BODY. THE SURGERY TOOK PLACE APPROXIMATELY FIVE WEEKS PRIOR TO THE EVENT. NO FURTHER INFORMATION WAS RECEIVED. UPDATE 12-FEB-2026 - FURTHER INFORMATION WAS RECEIVED: IT WAS REPORTED THAT ON (B)(6) 2025, THE IMPLANTED PLATE FRACTURED WHEN THE PATIENT BENT FORWARD WITH HER UPPER BODY. REVISION SURGERY TOOK PLACE ON (B)(6) 2025 AND WAS SUCCESSFULLY COMPLETED USING A NEW DEVICE WITH SAME PART NUMBER. THE PATIENT IS NOW SYMPTOM-FREE. THE PATIENT ORIGINALLY UNDERWENT SURGERY ON (B)(6) 2025, FOR A CLAVICLE FRACTURE.

  Patient problems: Failure of Implant

  MAUDE report 24483315 ↗
• InjuryApr 17, 2025Break; Break

  ON 3/31/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A PATIENT'S CLAVICLE FRACTURE PLATE BROKE. NO FURTHER INFORMATION WAS PROVIDED. ON 4/21/2025, A PATIENT¿S LEGAL REPRESENTATIVE REPORTED VIA EMAIL THAT A CLAVICLE PLATE FRACTURED. THE PLATE WAS IMPLANTED DURING AN OPEN REDUCTION INTERNAL FIXATION OF THE RIGHT CLAVICLE PERFORMED ON (B)(6) 2024. ON (B)(6) 2024, IMAGING SHOWED A BENT CLAVICLE PLATE. ON (B)(6) 2024, IMAGING SHOWED A FRACTURED CLAVICLE PLATE. ON (B)(6) 2025, THE PATIENT UNDERWENT A PROCEDURE TO REMOVE THE HARDWARE. THE RECORDS INDICATED PATIENT NONCOMPLIANCE WITH POSTOPERATIVE PROTOCOL CONTRARY TO THE CLAVICLE PLATE'S DIRECTIONS FOR USE.

  Patient problems: Failure of Implant; Foreign Body In Patient

  MAUDE report 21857669 ↗
• MalfunctionAug 22, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-2653CR CLAVICLE FRACTURE PLATE BROKE. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023: THIS WAS DISCOVERED DURING A CLAVICLE FRACTURE PROCEDURE. THE SALES REPRESENTATIVE IS UNSURE OF THE SURGERY DATE. THE PLATE WAS REMOVED, AND A PRODUCT FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 17597573 ↗
• InjuryApr 11, 2022Break

  ON 3/23/2022, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA MEDWATCH MAILED IN LETTER THAT AN AR-2653CR CLAVICLE FRACTURE PLATE WAS IMPLANTED IN (B)(6) 2021. WHILE PATIENT WAS PUTTING ON A COAT, THE PLATE SNAPPED IN HALF. THIS OCCURRED IN (B)(6) 2022. PATIENT HAD A REVISION SURGEON ON (B)(6) 2022 AND THE PLATE WAS EXPLANTED. LOT NUMBER FOR PLATE IS UNKNOWN AND NO FURTHER DETAILS HAVE BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 14075081 ↗
• InjuryJan 27, 2020Fracture

  IT WAS REPORTED BY THE (B)(6) THAT A PATIENT HAD A PRIMARY PROCEDURE ON (B)(6) 2019 IN WHICH AN AR-2653CR CLAVICLE FRACTURE PLATE CENTRAL THIRD (RIGHT) WITH INTER SCREWS WAS IMPLANTED. A REVISION RIGHT CLAVICLE HARDWARE REMOVAL PROCEDURE TOOK PLACE ON (B)(6) 2019 AND WAS PERFORMED BY THE SAME SURGEON WHO PERFORMED THE PRIMARY. THE REVISION PROCEDURE OPERATIVE REPORT NOTES AN ARTHREX TEN HOLE CLAVICLE PLATE (RIGHT) BROKE IN THE FIFTH SCREW SLOT FROM THE LATERAL EDGE. SURGEON ALSO NOTED THAT AT THE SIXTH SCREW HOLE THERE WAS BENDING OF THE PLATE NOT OBVIOUSLY APPRECIATED ON THE X-RAY. THE FOLLOWING ARTHREX PRODUCT WAS IMPLANTED DURING THE PRIMARY (B)(6) 2019 PROCEDURE, AND EXPLANTED DURING THE (B)(6) 2019 REVISION PROCEDURE; AR-2653CR // LOT: 6791239 // QTY.: 1, AR-2665-14H // LOT: 1003473 // QTY.: 1, AR-8835-10 // LOT: 031640 // QTY.: 2, AR-8835-12 // LOT: 10212120 // QTY.: 1, AR-8835-14 // LOT: 10325008 // QTY.: 3, AR-8835-14 // LOT: 10325012 // QTY.: 1, AR-8835-14 // LOT: 10325213 // QTY.: 1, AR-8835-16 // LOT: 10344449 // QTY.: 1, AR-8840-10 // LOT: 10010746 // QTY.: 1. THERE WAS NOT AN ARTHREX SALES REPRESENTATIVE PRESENT DURING THE REVISION PROCEDURE. THE LEAD NURSE REPORTED TO

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 9631368 ↗
• InjuryJun 25, 2019Break

  IT WAS REPORTED VIA THE PATIENT'S LEGAL REPRESENTATIVE THAT THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION OF RIGHT CLAVICLE FRACTURE PROCEDURE ON (B)(6) 2018 AFTER THE PATIENT HAD SUFFERED AN INJURY IN A MOTOR VEHICLE COLLISION APPROXIMATELY 5 WEEKS PRIOR. THE OPERATIVE REPORT FROM THE (B)(6) 2018 PROCEDURE NOTES THE PATIENT IS A SMOKER AND ALSO NOTES A HIGH RISK OF NON-UNION AND LARGE DISPLACEMENT GREATER THAN 100%. THE PATIENT CHOSE TO PROCEED WITH THE PROCEDURE AND DURING THE PROCEDURE THE FOLLOWING ARTHREX PRODUCT WERE RECORDED AS HAVING BEEN IMPLANTED: AR-2653CR (LOT 5261643) ¿ CLAVICLE PLATE QTY 1. AR-8835-16 (LOT 10204570) ¿ LOW PROFILE SCREW QTY 2. AR-8835-22 (LOT 10034710) ¿ LOW PROFILE SCREW QTY 1. AR-8835L-14 (LOT W50298) ¿ LOW PROFILE LOCKING SCREW QTY 2. AR-8835L-16 (LOT 10181718) ¿ LOW PROFILE LOCKING SCREW QTY 3. AR-8835L-18 (LOT 1194485) ¿ LOW PROFILE LOCKING SCREW QTY 1. AR-8835L-22 (LOT A43035)¿ LOW PROFILE LOCKING SCREW QTY 1. ON (B)(6) 2018 THE PATIENT UNDERWENT A REVISION SURGERY DUE TO POST OPERATIVE FIXATION FAILURE. THE OPERATIVE REPORT NOTED A RIGHT CLAVICLE HARDWARE REMOVAL AND RIGHT CLAVICLE OPEN REDUCTION INTERNAL FIXATION WITH INTERCALARY ST

  Patient problems: Failure of Implant

  MAUDE report 8732551 ↗
• InjuryMar 5, 2019Break

  IT WAS REPORTED THAT TWO MONTHS AFTER SURGERY THE PATIENT WENT TO THE SURGEON FOR CONSULTATION DUE TO PAIN. AN X-RAY WAS PERFORMED AND IT WAS CONFIRMED THAT THE PLATE THAT HAD BEEN PUT IN THE CLAVICLE WAS BROKEN. IT REQUIRED A SECOND SURGERY TO REMOVE THE PLATE AND REPLACE IT. UPDATE 12-FEB-2019: THE SECOND SURGERY WAS DONE A COUPLE WEEKS AGO WITH THE EXACT NOT YET DETERMINED. FURTHER INFORMATION REQUESTED. UPDATE 13-FEB-2019: THE FIRST SURGERY TOOK PLACE ON (B)(6) 2018. IT WAS FINISHED SUCCESSFULLY WITHOUT ANY PROBLEM. THE PLATE USED WAS THE AR-2653CR WITH BATCH NUMBER 5261640. A FEW MONTHS AFTER SURGERY THE PATIENT FELT PAIN AND CAME FOR A CONSULT. THEY MADE AN X-RAY AND FOUND THAT THE CLAVICULAR PLATE WAS BROKEN. A SECOND SURGERY WAS PERFORMED ON (B)(6) 2019. IT WAS PERFORMED BY THE SAME SURGEON AS THE FIRST SURGERY. THE PATIENT'S BROKEN PLATE WAS REMOVED AND REPLACED BY A NEW ONE FROM THE SAME PART NUMBER AND DIFFERENT BATCH NUMBER (AR-2653CR BATCH NUMBER 5261726). SINCE THE DAY OF THE SECOND SURGERY NO COMPLAINTS HAVE BEEN REPORTED.

  Patient problems: Pain

  MAUDE report 8390325 ↗
• InjuryDec 12, 2017Break

  IT WAS REPORTED BY THE REPRESENTATIVE THAT PER MALE PATIENT STATEMENT, HE WAS ON THE TREADMILL RUNNING NORMALLY AND CLAVICLE PLATE SNAPPED IN HALF. FOLLOW-UP INVESTIGATION: THE ORIGINAL SURGERY DATE WAS (B)(6) 2017. SURGEON STATED THAT THE TREADMILL INCIDENT WAS SEVERAL WEEKS PRIOR TO THE REVISION SURGERY WHICH TOOK PLACE ON (B)(6) 2017. TO COMPLETE THE REVISION PROCEDURE ANOTHER MANUFACTURER'S PLATE WAS IMPLANTED. DURING THE REVISION SURGERY THE FOLLOWING SCREWS WERE ALSO EXPLANTED: AR-4160-35 LOT 031617 QTY 1, AR-8835-12 LOT 031724 QTY 1, AR-8835-14 LOT 10144071 QTY 3, AR-8835-16 LOT 031716 QTY 4, AND AR-8835-16 LOT 031724 QTY 1.

  Patient problems: No Code Available

  MAUDE report 7108005 ↗
• InjuryJun 29, 2017Break

  IT WAS REPORTED THAT THE PLATE BROKE 5 1/2 MONTHS AFTER INSERTION AND NEEDED TO BE REVISED. INITIAL SURGERY ON (B)(6) 2016. REVISION SURGERY WAS ON (B)(6) 2017. A PLATE FROM ANOTHER MANUFACTURER WAS USED DURING REVISION SURGERY ALONG WITH A BONE GRAFT. PATIENT IS (B)(6) WITH PSEUDO-ARTHROSIS.

  Patient problems: No Code Available

  MAUDE report 6676501 ↗
• InjuryJun 2, 2017Break

  IT WAS REPORTED THAT THE PLATE BROKE 6 WEEKS AFTER FIRST SURGERY AND NEEDED TO BE REVISED. INITIAL SURGERY OF THE CLAVICULA FRACTURE PERFORMED ON (B)(6) 2017, SECOND SURGERY ON (B)(6) 2017, WHERE ANOTHER MANUFACTURER'S PLATE WAS USED AS A REPLACEMENT. THE PATIENT IS (B)(6) MALE, (B)(6). NO OTHER DETAILS GIVEN AT THIS TIME.

  Patient problems: Bone Fracture(s)

  MAUDE report 6607845 ↗