Arthrex® AR-13990Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867015906), received between Sep 18, 2017 and Jun 18, 2024 — classified as 1 injury, 4 malfunctions.

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

• MalfunctionJun 18, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT THE DEVICE HAS NO LABELING. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19560653 ↗
• MalfunctionMay 23, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE DEVICE IS ANODIZED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19388147 ↗
• MalfunctionMay 23, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE DEVICE IS ANODIZED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19388062 ↗
• MalfunctionMay 23, 2024Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE SUTURE DIDN´T PASS THROUGH THE TISSUE. THE NEEDLE DAMAGED THE SUTURE. NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY WAS REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A EXPRESS SUTURE PASSER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19387658 ↗
• InjurySep 18, 2017Break; Difficult to Remove

  IT WAS REPORTED THAT DURING AN AC JOINT REPAIR PROCEDURE, WHEN THE SURGEON WAS TRYING TO PASS SUTURE IN THE SUBACROMIAL SPACE, THE TIP OF THE SCORPION SUTURE PASSER BROKE OFF. THE TIP OF THE DEVICE WAS NOT RETRIEVED. PATIENT IS A (B)(6) MALE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6872390 ↗