Arthrex® AR-2665-22HRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867027749), received between Jun 13, 2022 and Jun 13, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 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) 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: ONE AR-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 14675065 ↗
• InjuryJun 13, 2022Fracture

  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) 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: ONE AR-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 14674877 ↗