Arthrex® AR-1386Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867015425), received between Feb 21, 2018 and Dec 26, 2019 — classified as 5 injuries.

The most frequently reported specific device problem is “Break” (5 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 26, 2019Break; Difficult to Remove

  IT WAS REPORTED THAT THE ARTHREX AR-1386 SCREWDRIVER WAS USED DURING ANTERIOR CRUCIATE LIGAMENT SURGERY. DURING INSERTION OF THE SCREW, THE TIP OF THE SCREWDRIVER HAS BROKEN OFF INSIDE THE SCREW. IT WAS NOT POSSIBLE FOR THE SURGEON TO REMOVE THE TIP. THE PATIENT IS VERY YOUNG. THE PARENTS AND THE PATIENT WERE INFORMED ABOUT THE INCIDENT. THE SURGERY WAS STILL COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9519620 ↗
• InjuryOct 1, 2019Break

  IT WAS REPORTED THAT THE TIP OF SCREWDRIVER BROKE INSIDE THE SCREW DURING IMPLANTATION. UPDATE 10-SEPT-2019: AN ANTERIOR CRUCIATE LIGAMENT (ACL) PROCEDURE WAS PERFORMED. THE BROKEN PIECE REMAINED IN THE SCREW INSIDE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9141367 ↗
• InjuryJan 30, 2019Break

  IT WAS REPORTED THAT DURING A ANTERIOR CRUCIATE LIGAMENT SURGERY, WHEN SCREWING THE FEMORAL SCREW, THE SCREWDRIVER BROKE. 1 FRAGMENT REMAINED IN THE FEMORAL SCREW AND IT IS NOT POSSIBLE TO REMOVE IT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE WHICH WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 10TH. JAN. 2019: THE BROKEN PIECE IS SET UP INSIDE THE SCREW, WELL IMPLANTED INTO THE BONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8288790 ↗
• InjuryJun 7, 2018Break

  IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER BROKE INSIDE THE BIOABSORBABLE SCREW. THE BROKEN FRAGMENT WAS NOT REMOVED BUT REMAINED INSIDE THE SCREW AND WAS FIXED THERE. THE SURGERY WAS COMPLETED SUCCESSFULLY, NO NEGATIVE CONSEQUENCES FOR THE PATIENT HAVE BEEN REPORTED SO FAR. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. FOLLOW-UP INVESTIGATION: AN X-RAY WAS DONE, BUT NO COMPUTERIZED PICTURE IS AVAILABLE. THE TRANSPLANT IS BLOCKED IN THE FEMUR TUNNEL WITH THE SCREW. THE SURGEON WAS NOT ABLE TO GIVE MORE INFORMATION. THE PART NUMBER OF THE SCREW IS AR-1370B WITH BATCH NO. 10169107.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7577715 ↗
• InjuryFeb 21, 2018Break; Difficult to Remove

  IT WAS REPORTED THAT THE AR-1380B BROKE, THEN THE AR-1390B, THEN THE SCREWDRIVER BROKE. THE TIP OF THE SCREW DRIVER REMAINED IN THE PATIENT. THE FRAGMENTS OF THE SCREWS WERE REMOVED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7285128 ↗