Arthrex® AR-2652CRRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867027435), received between Mar 1, 2017 and Aug 8, 2025 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 8 most recent of 8 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 22750446 ↗
• InjurySep 27, 2024Break; Break

  IT WAS REPORTED THAT DURING A X-RAY CHECK-UP, WHICH WAS CARRIED OUT 1 MONTH AFTER THE OPERATION, IT WAS FOUND THAT THE ARTHREX PLATE FOR THE CLAVICLE WAS BROKEN IN THE MIDDLE. THERE WAS NO SECOND SURGERY AND THE DEVICE REMAINED IN THE PATIENT.

  Patient problems: Failure of Implant; Foreign Body In Patient

  MAUDE report 20321764 ↗
• MalfunctionJun 13, 2022Break

  ON (B)(6) 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) 20222 TO REMOVE ALL THE IMPLANTED SCREWS ALONG WITH THE BROKEN PLATE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14674345 ↗
• InjuryDec 21, 2020Break

  IT WAS REPORTED THAT THE FEMALE PATIENT (UNKNOWN AGE) HAD A CLAVICLE FRACTURE CASE DONE ON (B)(6) 2020. POST-OP, THE PLATE BROKE IN HALF ALONG THE OBLONG SCREW HOLE (UNKNOWN IF THERE WAS AN EVENT THAT CAUSED THE BREAK). ON (B)(6) 2020, THERE WAS A REVISION CASE DONE TO REMOVE THE PLATE AND IT WAS REPLACED WITH ANOTHER PLATE (UNKNOWN PART).

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 11046652 ↗
• InjuryFeb 25, 2020Break

  IT WAS REPORTED THAT A COUPLE OF WEEKS AFTER AN INITIAL SURGERY THE CLAVICLE PLATE BROKE OVER THE OBLONG HOLE. A REVISION SURGERY WAS PERFORMED TO ADDRESS THE ISSUE. 17-FEB-2020: FURTHER INFORMATION RECEIVED THAT THE INITIAL SURGERY WAS A CLAVICLE FRACTURE SURGERY AND WAS PERFORMED ON (B)(6) 2019 AND THE REVISION SURGERY TOOK PLACE ON (B)(6) 2020. THE PLATE WAS REPLACED WITH ANOTHER MANUFACTURER'S FRACTURE PLATE AND THE SURGERY WAS SUCCESSFUL.

  Patient problems: No Code Available

  MAUDE report 9750664 ↗
• InjuryFeb 17, 2020Break

  IT WAS REPORTED THAT A PATIENT HAD UNDERGONE A TOTAL KNEE REPLACEMENT AND A WEEK LATER ON (B)(6) 2019 THE PATIENT STATES HE GOT UP DURING THE NIGHT AND BLACKED OUT (POSSIBLY DUE TO MEDICATION BEING TAKEN AS A RESULT OF HIS KNEE REPLACEMENT PROCEDURE) CAUSING HIM TO FALL WHICH CAUSED A FRACTURED CLAVICLE. THE PATIENT UNDERWENT A SURGERY ON (B)(6) 2019 DURING WHICH AN ARTHREX CLAVICLE PLATE AR-2652CR (LOT 5261748) AND 7 SCREWS (AR-8835L-14 (QTY 2), AR-8835L-16 (QTY 2), AR-8835-14 (QTY 1) AND AR-8835-16 (QTY 2)) WERE IMPLANTED. THE PATIENT REPORTED THAT HE WAS NOT EXPERIENCING ANY PAIN AFTER THE SURGERY UNTIL APPROXIMATELY 4 WEEKS POST OP WHEN HE BEGAN TO EXPERIENCE PAIN IN THE SURGICAL AREA WHICH HE REPORTED WAS ABOUT A 3-4 OUT OF 10. THE PATIENT HAD A PLANNED FOLLOW UP APPOINTMENT WITH THE SURGEON SCHEDULED FOR (B)(6) 2020 SO HE CHOSE TO WAIT UNTIL THE FOLLOW UP TO DISCUSS WITH SURGEON. THE DAY BEFORE HIS APPOINTMENT HE BEGAN EXPERIENCING SHOOTING PAIN AT A LEVEL OF 9 OUT OF 10. AT THE (B)(6) FOLLOW UP APPOINTMENT X-RAYS WERE TAKEN WHICH SHOWED THE SCREWS IN PLACE BUT THE CLAVICLE PLATE APPEARED TO BE SHAPED LIKE A V. THIS (B)(6) X-RAY WAS COMPARED TO THE ORIGINAL POST-OP X-RAY AND

  Patient problems: Failure of Implant; Pain

  MAUDE report 9717451 ↗
• InjuryJul 7, 2017Break

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT A CLAVICLE FRACTURE PROCEDURE WHERE A CLAVICLE FRACTURE PLATE (LOT: 5231615, LINE 197326) WAS IMPLANTED. THE PATIENT HAD REPORTED TO SURGEON THAT HE WAS DRIVING, HAD TO HIT HIS BRAKES, AND THE PLATE BROKE. THE PLATE WAS REMOVED ON (B)(6) 2017 AND REPLACED WITH ANOTHER MANUFACTURER'S PLATE. ALL ORIGINAL SCREWS WERE ALSO EXPLANTED. SCREW PART AND LOT NUMBERS WERE NOTE PROVIDED.

  Patient problems: Bone Fracture(s)

  MAUDE report 6692683 ↗
• InjuryMar 1, 2017Fracture

  IT WAS REPORTED VIA MEDWATCH ((B)(4)) THAT A PATIENT UNDERWENT A REVISION RIGHT CLAVICLE OSTEOTOMY ON (B)(6) 2017 DUE A BROKEN AR-2652CR CLAVICLE FRACTURE PLATE WHICH REQUIRED REMOVAL DUE TO MALUNION. ADDITIONAL INFORMATION OBTAINED 02/13/2017: THE ORIGINAL SURGERY DATE WAS (B)(6) 2016. PLATE WAS BROKEN POST-OP. DURING THE REVISION THE SURGEON EXPLANTED THE AR-2652CR CLAVICLE FRACTURE PLATE ((B)(4)). TO REMOVE THE BROKEN PLATE THE SURGEON ALSO EXPLANTED THE FOLLOWING SCREWS FROM THE ORIGINAL (B)(6) 2016 SURGERY: AR-8835L-16 LOCKING SCREW, AR-8835-20 CORTICAL SCREW, AR-8835-22 CORTICAL SCREW, AR-8835-24 CORTICAL SCREW AND AR-8830-20 CANCELLOUS SCREW. THE PROCEDURE WAS COMPLETED USING NON-ARTHREX PRODUCTS.

  Patient problems: Failure of Implant

  MAUDE report 6368816 ↗