Arthrex® AR-1562CDSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867233980), received between Dec 9, 2019 and Dec 5, 2023 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2023Break; Break

  ON 11/09/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-1562CDS BIOCOMPOSITE TENODESIS SCREW SUTURE LOOP BROKE DURING INSERTION. THIS WAS DISCOVERED DURING AN ACHILLES TENDON RUPTURE PROCEDURE ON (B)(6) 2023. THE CASE WAS COMPLETED USING A NEW PRODUCT. ADDITIONAL INFORMATION RECEIVED ON 11/14/2023: AS THE AR-1562CDS BIOCOMPOSITE TENODESIS SCREW WAS BEING INSERTED, THE LOOP STARTED TO BREAK GRADUALLY AS IT WAS BEING SCREWED INTO THE BONE HOLE. ALL THE BROKEN FRAGMENTS WERE REMOVED. THE CASE WAS COMPLETED AR-1562CDS BIOCOMPOSITE TENODESIS SCREW. THE CASE WAS NOT DELAYED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18271168 ↗
• InjuryDec 9, 2019Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT BONESYNC, ABS-3103, WAS BEING USED IN AN ANKLE CASE. THE PATIENT HAD A PREVIOUS CALCANEAL FRACTURE, THAT WAS AGAIN REFRACTURED AT THE INSERTION SITE OF THE ACHILLES TENDON. THE LARGE FRAGMENT WAS PINNED AND PATIENT RETURNED FOR REPAIR OF THE ACHILLES¿ TENDON. PATIENT HAS A HISTORY OF SMOKING. AFTER INSERTION OF THE FIRST ANCHOR OF THE SPEEDBRIDGE IMPLANT SYSTEM, THE ANCHOR PULLED OUT DUE TO VERY POOR BONE QUALITY. THE SURGEON INCREASED THE SIZE OF THE ANCHOR TO A 5.5 SWIVELOCK, BUT ULTIMATELY, IT STILL PULLED OUT. AT THIS POINT, THE REP RECOMMENDED THE USE OF BONE SYNC. AFTER QUICK APPROVAL FROM THE FACILITY, THE REP RETRIEVED 3CC OF BONESYNC, ABS-3103. HE REVIEWED THE INDICATIONS AND TECHNIQUE PROVIDED BY ARTHREX AND AFTER DISCUSSING WITH THE DOCTOR AND DUE TO TIME SENSITIVITY (PATIENT WAS ON THE TABLE FOR AN HOUR AND A HALF AT THIS POINT), SURGEON DECIDED TO USE ROOM TEMPERATURE SALINE INSTEAD OF BLOOD - BOTH INDICATED AND VIABLE SOLUTIONS TO USE WHEN MIXING WITH THE BONE CEMENT POWDER. SURGEON MIXED 3CC OF BONESYNC WITH 2.8CC OF SALINE (2.6CC FOR FASTER SETTING, 2.8CC FOR FACILITATED MIXING REQUIRING A SLIGHTLY LONGER SET TIME). REP WHO WAS PRESENT STATED TH

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9438176 ↗