Arthrex® AR-7268TRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867369900), received between Nov 27, 2024 and Nov 27, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 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. How this data works · Data updated Oct 13, 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.

• InjuryNov 27, 2024Break; Break

  ON 10/29/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A 3024-016 16-HOLE LEFT ALPHA PLATE BROKE POSTOPERATIVELY THROUGH THE OBLONG HOLE IN THE FIRST BEND OF THE PLATE. ON (B)(6) 2024, THE PATIENT WAS IMPLANTED WITH THE PLATE, AND ON (B)(6) 2024, THE PLATE WAS REMOVED. PER THE SALES REPRESENTATIVE, THE PATIENT DID NOT REPORT ANY FALLS OR INJURIES. NO ADDITIONAL INFORMATION HAS BEEN REPORTED. ADDITIONAL INFORMATION RECEIVED ON 11/13/2024: THE CORRECT ORIGINAL SURGERY DATE IS (B)(6) 2024. THE PATIENT WAS IMPLANTED WITH THE 3024-016 16-HOLE LEFT ALPHA PLATE, AN 8110-026 CORTICAL BONE SCREW, TWO 8110-028 CORTICAL BONE SCREWS, FOUR 8114-026 DOUBLE LEAD LOCK CORTICAL SCREW, AN 8114-036 DOUBLE LEAD LOCK CORTICAL SCREW, AN 8124-030 FULLY THREADED CANCELLOUS LOCKING SCREW, AN 8124-032 FULLY THREADED CANCELLOUS LOCKING SCREW, TWO 8124-036 FULLY THREADED CANCELLOUS LOCKING SCREW, TWO 8124-040 FULLY THREADED CANCELLOUS LOCKING SCREW, AN 8124-042 FULLY THREADED CANCELLOUS LOCKING SCREW, TWO AR-7268T TIGERTAPE CERCLAGE WITH FIBERLINK SHUTTLE SUTURE, AND AN ABS-2010-10 ALLOSYNC PURE. DURING THE REVISION SURGERY, ALL THE HARDWARE WAS REMOVED. THE REVISION SURGERY WAS COMPLETED USI

  Patient problems: Failure of Implant

  MAUDE report 20791488 ↗
• InjuryNov 27, 2024Break; Break

  ON 10/29/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A 3024-016 16-HOLE LEFT ALPHA PLATE BROKE POSTOPERATIVELY THROUGH THE OBLONG HOLE IN THE FIRST BEND OF THE PLATE. ON (B)(6) 2024, THE PATIENT WAS IMPLANTED WITH THE PLATE, AND ON (B)(6) 2024, THE PLATE WAS REMOVED. PER THE SALES REPRESENTATIVE, THE PATIENT DID NOT REPORT ANY FALLS OR INJURIES. NO ADDITIONAL INFORMATION HAS BEEN REPORTED. ADDITIONAL INFORMATION RECEIVED ON 11/13/2024: THE CORRECT ORIGINAL SURGERY DATE IS (B)(6) 2024. THE PATIENT WAS IMPLANTED WITH THE 3024-016 16-HOLE LEFT ALPHA PLATE, AN 8110-026 CORTICAL BONE SCREW, TWO 8110-028 CORTICAL BONE SCREWS, FOUR 8114-026 DOUBLE LEAD LOCK CORTICAL SCREW, AN 8114-036 DOUBLE LEAD LOCK CORTICAL SCREW, AN 8124-030 FULLY THREADED CANCELLOUS LOCKING SCREW, AN 8124-032 FULLY THREADED CANCELLOUS LOCKING SCREW, TWO 8124-036 FULLY THREADED CANCELLOUS LOCKING SCREW, TWO 8124-040 FULLY THREADED CANCELLOUS LOCKING SCREW, AN 8124-042 FULLY THREADED CANCELLOUS LOCKING SCREW, TWO AR-7268T TIGERTAPE CERCLAGE WITH FIBERLINK SHUTTLE SUTURE, AND AN ABS-2010-10 ALLOSYNC PURE. DURING THE REVISION SURGERY, ALL THE HARDWARE WAS REMOVED. THE REVISION SURGERY WAS COMPLETED USI

  Patient problems: Failure of Implant

  MAUDE report 20790660 ↗