Arthrex® AR-1380TRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867015333), received between May 17, 2018 and May 17, 2018 — classified as 1 injury.

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.

• InjuryMay 17, 2018Break

  IT WAS REPORTED THAT DURING AN ACL REVISION (WHICH INVOLVED REMOVAL OF TITANIUM INTERFERENCE SCREWS FROM A PREVIOUS SURGERY) AND A MENISCAL ROOT REPAIR PROCEDURE, THE SURGEON PREPARED THE BTB ALLOGRAFT WITH #5 FIBERWIRE AND #2 FIBERWIRE. THE FEMORAL SOCKET WAS PREPARED THROUGH THE MEDIAL PORTAL WITH THE OVER-THE-TOP GUIDE AND 2.4 MM BEATH PIN, FOLLOWED BY A 10 MM LOW PROFILE REAMER TO A DEPTH OF 30 MM. THE TIBIAL TUNNEL WAS PREPARED WITH AN ACUFEX GUIDE, 2.4 MM DRILL TIP PIN, AND 10 MM CANNULATED DRILL. THE GRAFT WAS PASSED WITH A #2 FIBERWIRE THROUGH THE TIBIAL TUNNEL AND INTO THE FEMORAL SOCKET. AN 8 MM TAP WITH DISPOSABLE SHEATH AND TUNNEL NOTCHER WAS USED ON THE FEMORAL SOCKET. AN 8 X 23 MM BIOCOMPOSITE INTERFERENCE SCREW W/ DISPOSABLE SHEATH (AR-1380BC, LOT: 10051207, (B)(4)) WAS INSERTED AND BROKE WHILE THE SURGEON WAS INSERTING IT. ALL FRAGMENTS OF THIS SCREW WERE REMOVED AND A 7 MM TAP WAS USED TO RE-TAP THE FEMORAL SOCKET. A SECOND SCREW, A 7 X 23 MM BIOCOMPOSITE INTERFERENCE SCREW W/ DISPOSABLE SHEATH (AR-1370C, LOT: 10192231, (B)(4)) WAS INSERTED AND THIS SCREW BROKE AS WELL AS THE SURGEON WAS INSERTING IT. ALL FRAGMENTS OF THIS SCREW WERE REMOVED. AT THIS POINT A DIFFER

  Patient problems: No Code Available

  MAUDE report 7521508 ↗