Arthrex® AR-13999HDN-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867374010), received between Jun 27, 2024 and Jan 20, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2026Break

  IT WAS REPORTED THAT DURING A SURGERY, THE TIP OF THE NEEDLE BROKE OFF. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. FURTHER INFORMATION WAS REQUESTED. UPDATE 14-JAN-2026: IT WAS REPORTED THAT DURING THE ARTHROSCOPIC ROTATOR CUFF REPAIR, THE TIP OF THE NEEDLE BROKE OFF. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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. UPDATE 14-JAN-2026: THE SURGERY WAS DELAYED BY 45 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24115493 ↗
• MalfunctionOct 10, 2024Break; Break

  IT WAS REPORTED THAT DURING A CUFF REPAIR SURGERY THE NEEDLE STOPPED FIRING THE SUTURE THROUGH THE TISSUE. UPON INSPECTION THE STAFF NOTICED THAT THE NEEDLE HAD SNAPPED AT THE TIP. THE NEEDLE TIP COULD NOT BE LOCATED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE ( S&N FIRST PASS). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20417037 ↗
• MalfunctionJun 27, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A ROTATOR CUFF RECONSTRUCTION SURGERY THE DEVICE WAS BENT. THE TAPE NO LONGER PASSED THROUGH THE ROTATOR CUFF. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19622348 ↗