Arthrex® AR-1675BC-CPRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867020771), received between Jun 18, 2019 and May 22, 2024 — classified as 2 injuries, 1 malfunction.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 03/30/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT ANT AR-1675BC-CP LATERAL ANKLE RECONSTRUCTION IMPLANT SYSTEM HAD THE ANCHOR PULL OUT OF IMPLANTATION SITE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19371431 ↗
• InjuryAug 17, 2021Break; Material Puncture/Hole

  IT WAS REPORTED DURING A LATERAL ANKLE ALLOGRAPH RECONSTRUCTION THE FIBER WIRE WAS CUT DURING INSERTION. ANOTHER FIBER WIRE WAS USED AND WAS TORN AND BROKE AGAIN. A THIRD TIME WAS ATTEMPTED AND THE SAME EVENT OCCURRED. THE SURGEON LAID THE TENDON INTO THE HOLE AND PUSHED IT IN WITH THE SCREW. THE CASE WAS COMPLETED WITH NO FURTHER ISSUES. THE PATIENT IS FINE TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12332936 ↗
• InjuryJun 18, 2019Migration or Expulsion of Device; Positioning Problem

  IT WAS REPORTED THAT A LATERAL ANKLE RECONSTRUCTION IMPLANT SYSTEM, AR-1675BC-CP, WAS BEING USED DURING A LATERAL ANKLE RECONSTRUCTION PROCEDURE. THE 5.5MM BIO-TENODESIS SCREW WAS BEING IMPLANTED INTO THE LATERAL TALUS. UPON INSERTION, THE SURGEON MISSED THE BONE TUNNEL (THAT WAS PREPARED USING 5.5MM REAMER FROM THE KIT). HE COULD NOT LOCATE THE SCREW IN THE JOINT AND THINKS THAT IT MAY HAVE WENT INTO/AROUND THE LATERAL ASPECT OF THE SINUS TARSI. HE MADE EVERY ATTEMPT TO LOCATE AND REMOVE THE SCREW BUT COULD NOT FIND IT. HE DECIDED TO LEAVE IT IN THE PATIENT UNSECURED. THE REST OF THE PROCEDURE WAS COMPLETED WITH NO FURTHER INCIDENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 8707149 ↗