Arthrex® AR-1529Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867018556), received between Feb 14, 2022 and Feb 14, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 14, 2022Improper or Incorrect Procedure or Method; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN ARTHRO ASSISTED LATARJET SURGERY THE PATIENT¿S CORACOID WAS TORN THROUGH BY THE FIBERTAPE CERCLAGE SYSTEM AND HALF OF THE GLENOID WAS TORN THROUGH DUE TO A MISUNDERSTANDING REGARDING THE USED TENSIONER AND THE SCALE, WHICH LED TO A FALSE ADJUSTMENT OF THE TENSIONER OF ABOVE 350 NEWTONS. TWO TENSIONERS WERE SENT OUT FOR THIS CASE WHICH WAS AN ARTHROSCOPIC ASSISTED LATARJET CERCLAGE. THE TENSIONER LISTED (AR-7800 AND AR-7801) PLUS THE BLUE ACL TENSIONER AR-1529. AR-1529 IS THE TENSIONER THAT WAS PREVIOUSLY ALWAYS USED BY THE ARTHREX EMPLOYEE, WHICH MAX¿S OUT AT JUST OVER 100 NEWTONS WITH THE UNIT OF MEASURE LISTED ON THERE IN LBF AND NEWTONS. THE CASE WENT REALLY WELL UNTIL TENSIONING WHERE THE ARTHREX EMPLOYEE DIDN¿T REALISE THAT THE SURGEON WAS USING THE BLACK TENSIONER (AR- 7800 & AR-7801). THIS TENSIONER DOESN¿T HAVE THE UNIT OF MEASURE LISTED ON IT, AND THE SCALE IS IN LBF. THE SURGEON ASKED HOW MUCH TO TENSION TO AND THE ARTHREX EMPLOYEE REPLIED THAT THE SURGEON CAN MAX THE TENSIONER OUT AS 100 NEWTONS ARE DESIRED, IT MAX¿S OUT AT THAT POINT. THE SURGEON THEN TENSIONED TO AROUND 80 IN LBF SCALE, WHICH WAS OVER 350 NEWTONS. THE PATIENT¿S CORACOID W

  Patient problems: Insufficient Information

  MAUDE report 13526856 ↗