Arthrex® AR-4020HT-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867291980), received between Aug 15, 2022 and Aug 15, 2022 — classified as 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 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.

• MalfunctionAug 15, 2022Break

  ON 7/22/2022, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT AR-4020HT-07 FASTTHREAD SCREW TAP SHREDDED THE SUTURE TAPE UPON TAPPING THE TIBIAL TUNNEL. AT THIS POINT, THE GRAFT WAS ALREADY FIXED ON THE FEMUR, SO SURGEON WAS LEFT TO PASS A 22 GAGE WIRE THROUGH THE TIBIAL BONE BLOCK BEFORE ATTAINING TENSION ONCE MORE AND FIXATING THE GRAFT. THIS ADDED 20 MINUTES TO THE SURGERY AND ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT. TAP HANDLE BROKE FORM THE TAP SHAFT DURING THE TAPPING OF THE FEMORAL ACL SOCKET. ALL BROKEN PIECES WERE RETRIEVED. THIS WAS DISCOVERED DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION, BONE PATELLAR BONE TECHNIQUE OF THE LEFT KNEE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 15223650 ↗