Arthrex® AR-1588TB-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867157729), received between Aug 21, 2019 and Oct 12, 2021 — 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.

• InjuryOct 12, 2021Therapeutic or Diagnostic Output Failure

  ON (B)(6) 2021, IT WAS REPORTED BY SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1588TNT FIBERTAG ABS TIGHTROPE FAILED TO PROPERLY TENSION DOWN AR-1588TB-3 ABS BUTTON. THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION, SURGEON HAD TO USE A SWIVELOCK TO COMPLETE CASE. ADDITIONAL INFO REQUESTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12615403 ↗
• InjuryAug 21, 2019Break; Material Fragmentation

  IT WAS REPORTED DURING A REVISION ACL PROCEDURE, UPON INSERTING THE FEMORAL AR-4020C-07 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW (LOT: 10248522) THE SCREW CRUMBLED INTO MULTIPLE PIECES AFTER ONE AND A HALF TURNS. THE REP CONFIRMED ALL BROKEN PIECES OF THE SCREW WERE RETRIEVED BY USING A GRASPER. A SECOND AR-4020C-07 FROM A DIFFERENT LOT (LOT: 10262903) WAS BROUGHT IN. UPON INSERTING, THE SCREW BROKE INTO TWO HALVES AFTER ONE AND A HALF TURNS. THE REP CONFIRMED ALL PIECES WERE FULLY REMOVED BY USING A GRASPER. ANOTHER MANUFACTURER'S SCREW WAS BROUGHT IN AND USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE. ONLY ONE SCREW IS AVAILABLE TO RETURN (LOT: 10262903) AS THE OTHER SCREW WAS DISCARDED. THE REP STATED THE REVISION TOOK PLACE DUE THE PATIENT RE-TEARING THEIR ACL. THE ORIGINAL IMPLANTED ARTHREX TIGHTROPE AND FIBERWIRE WERE EXPLANTED DURING THE REVISION.*ADDITIONAL INFORMATION RECEIVED ON 08/01/2019:THE REP CONFIRMED THE REVISION WAS DUE TO RE-INJURY AND WAS NOT IMPLANT RELATED. THE PRIMARY PROCEDURE WAS A QUAD TENDON AUTOGRAFT, SOFT TISSUE. THE PRIMARY AND REVISION PROCEDURE WERE PERFORMED BY THE SAME SURGEON AND TOOK PLACE AT THE SAME FACILITY. THE SURGEON REVISED WITH A

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8917041 ↗