Arthrex® AR-2657DRRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867027534), received between Sep 28, 2016 and Oct 30, 2025 — classified as 8 injuries, 1 malfunction.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2025Use of Device Problem; Patient Device Interaction Problem; Use of Device Problem; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON 11/25/2026: THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2025. NO ARTHREX PRODUCTS WERE IMPLANTED DURING THE PROCEDURE. THE REVISION WAS COMPLETED SUCCESSFULLY WITHOUT ANY CASE DELAYS OR ADDITIONAL ANESTHESIA. THE PATIENT¿S CURRENT HEALTH STATUS FOLLOWING THE REVISION WAS REPORTED AS GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information; Pain

  MAUDE report 23423541 ↗
• InjurySep 26, 2024Break; Break

  UPDATE KPILZ 29-OCT-2024: FURTHER INFORMATION WAS PROVIDED THAT A REVISION SURGERY OCCURRED ON (B)(6) 2024. ALL PARTS WERE RETRIEVED FROM THE PATIENT. THE SURGEON IMPLANTED THE DEVICE VARIAX STYKER. ALL PARTS WERE DISCARDED.

  Patient problems: Failure of Implant; Foreign Body In Patient

  MAUDE report 20311516 ↗
• InjuryMar 1, 2021Break

  IT WAS REPORTED BY THE PATIENT MOTHER THAT WHILE HER SON WAS PLAYING BASEBALL ON (B)(6) 2021, RAN FOR CATCH AND HIT A WALL THE AR-2657DR, PLATE IN HIS SHOULDER SNAPPED. ORIGINAL SURGERY WAS (B)(6) 2021. REVISION SURGERY SCHEDULED FOR (B)(6) 2021.

  Patient problems: Failure of Implant

  MAUDE report 11392581 ↗
• InjurySep 2, 2020Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE WHERE A DISTAL CLAVICLE PLATE, AR-2657DR, WAS IMPLANTED INTO THEIR RIGHT SHOULDER. AT SOME POINT AFTER THE PROCEDURE, THE PLATE BROKE AND THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2020 WHERE A SECOND DISTAL CLAVICLE PLATE, AR-2657DR, WAS IMPLANTED. THE EXPLANTED BROKEN PLATE WAS DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10482492 ↗
• InjurySep 2, 2020Break

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE A DISTAL CLAVICLE PLATE, AR-2657DR, WAS IMPLANTED INTO THEIR SHOULDER. THE REVISION WAS TO REPLACE A DISTAL CLAVICLE PLATE THAT WAS IMPLANTED AND HAD CRACKED POST-OP. ABOUT 12 WEEKS POST-OP OF THE REVISION, ON (B)(6) 2020, THE PATIENT REPORTED LIFTING HIS ARM UP IN THE AIR AND FEELING A "CRACK." A SECOND REVISION PROCEDURE IS BOOKED FOR REMOVAL OF THE SECOND BROKEN PLATE ON (B)(6) 2020. ADDITIONAL INFORMATION PROVIDED 8/19/2020: THE REPLACEMENT PLATE BROKE 12 WEEKS POST-OP; X-RAYS HAVE BEEN REQUESTED. THE PLATE THAT BROKE WAS THE REPLACEMENT PLATE THAT WAS IMPLANTED DURING THE (B)(6) 2020 REVISION PROCEDURE (CAPTURED ON CASE 48491). IT¿S BEEN CONFIRMED THAT THE REVISION SCHEDULED FOR (B)(6) 2020 HAS TAKEN PLACE. ADDITIONAL INFORMATION PROVIDED 9/4/2020: THE INITIAL SURGERY WAS PERFORMED ON 9/29/2019. NO PLATE WAS IMPLANTED AFTER THIS SECOND INCIDENT. THE SAME SURGEON COMPLETED ALL THREE PROCEDURES ON THIS PATIENT. SEE ATTACHED X-RAYS OF THE NEW PLATE AFTER BEING IMPLANTED AND THAT SAME PLATE BROKEN ON JUNE 30, 2020.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10482147 ↗
• InjuryMar 18, 2019Break

  IT WAS REPORTED THAT THE PLATE BROKE IN HALF FEW DAYS AFTER THE SURGERY. UPDATE 25-FEB-2019: WE RECEIVED X-RAYS OF THE FIRST AND SECOND SURGERY. X-RAYS TAKEN ON (B)(6) 2018 SHOW FRACTURE OF CLAVICULA, X-RAYS AFTER INITIAL SURGERY TAKEN ON (B)(6) 2018 SHOW THAT PLATE IS INTACT. REVISION SURGERY WAS PERFORMED ON (B)(6) 2019, FINAL X-RAYS TAKEN ON (B)(6) 2019 SHOW THAT PLATE FROM REVISION SURGERY IS INTACT. NO FURTHER INFORMATION HAVE BEEN MADE AVAILABLE BY REPORTER.

  Patient problems: No Code Available

  MAUDE report 8427925 ↗
• InjuryDec 27, 2017Break; Noise, Audible

  IT WAS REPORTED THAT THE DISTAL CLAVICLE PLATE BROKE POST-OP. INITIAL SURGERY WAS ON (B)(6) 2017. REVISION SURGERY WAS DONE ON (B)(6) 2017. FOLLOW-UP INVESTIGATION: THE CLAVICLE PLATE BROKE 2 WEEKS POST-OP, THE PATIENT WAS IN THE SHOWER AND HEARD A SNAP. PATIENT DID NOT FALL AND WAS NOT UNDER TRAUMA. THE SURGEON ASSURES THAT THE PATIENT WAS COMPLIANT WITH THE POST-OP GUIDELINES. PATIENT: MALE, (B)(6). ON THE REVISION SURGERY THE BROKEN IMPLANT WAS COMPLETELY REMOVED AND A NEW IMPLANT - AR-2653CR WAS IMPLANTED.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7147517 ↗
• InjuryNov 10, 2017Fracture

  IT WAS REPORTED THAT THERE WAS A PLATE FRACTURE AFTER THE SURGERY (EIGHT MONTHS). THERE WAS NO HEALING / PSEUDARTHROSIS. PATIENT HAD NO PAIN UNTIL THE PLATE WAS BROKEN. PATIENT SAID THAT THE PAIN APPEARED AFTER MAXIMAL HYPER ADDUCTION/ EXTERNAL ROTATION WITHOUT FORCEFUL IMPACT. A REVISION SURGERY WAS NECESSARY.

  Patient problems: Pain

  MAUDE report 7017721 ↗
• InjurySep 28, 2016Break

  IT WAS REPORTED THAT A RIGHT, 8 HOLE, DISTAL CLAVICLE PLATE, AR-2657DR, WAS USED IN A RIGHT CLAVICLE FRACTURE PROCEDURE ON (B)(6) 2016 APPROXIMATELY 2 MONTHS AFTER THE PROCEDURE, THE PLATE WAS DISCOVERED TO HAVE BROKEN. IT WAS REPORTED THAT THE PATIENT DID NOT HAVE A TRAUMA OR INJURY POST-IMPLANTATION. THE PLATE AND SCREWS WERE EXPLANTED ON (B)(6) 2016. NO SCREWS WERE BROKEN. THE REVISION PROCEDURE WAS COMPLETED USING ANOTHER PRODUCT. PATIENT: FEMALE.

  Patient problems: No Code Available

  MAUDE report 5983849 ↗