Arthrex® AR-13995Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867015944), received between Jul 31, 2018 and Feb 23, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• MalfunctionFeb 23, 2026Break

  ON 05-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT THE AR-13995 SCORPION-MULTIFIRE HAD A NEEDLE BREAK. THIS ISSUE WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24415829 ↗
• MalfunctionJul 21, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE NEEDLE BROKE OFF AT THE TIP. THE BROKEN PART WAS LEFT INSIDE THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22558113 ↗
• MalfunctionApr 3, 2025Break; Break

  ON 03/14/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-13995 SCORPION NEEDLE BROKE OFF INSIDE ROTATOR CUFF. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. THE FRAGMENT WAS UNABLE TO BE RETRIEVED. THE CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21766519 ↗
• MalfunctionDec 22, 2023Crack; Crack

  ON 11/27/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-13995 MULTIFIRE SCORPIONS TOP JAW WAS CRACKED. THIS OCCURRED DURING A CASE, WITH NO EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18386075 ↗
• MalfunctionJul 31, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SUTURE WAS NOT MOVED FORWARD DURING A SURGERY, THEY HAVE TESTED THE DEVICE AFTERWARDS AND IT WORKED THERE. ADDITIONAL INFORMATION OBTAINED 7/16/18: THE PERFORMED SURGERY WAS AN SHOULDER ARTHROSCOPY. BECAUSE OF THE INCIDENT THE SURGEON NEEDED TO DO A BIGGER CUT AND ALSO THE SURGERY TOOK 10 MINUTES LONGER THEN EXPECTED (INITIAL SURGERY TIME 1 HOUR) . THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A CHANGED TECHNIQUE - FROM ARTHROSCOPY TO OPEN.

  Patient problems: No Code Available

  MAUDE report 7734640 ↗