Arthrex® AR-13998Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867015999), received between Feb 16, 2023 and Mar 26, 2026 — classified as 4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT DURING THE LABRUM REFIXATION, THE NEEDLES BROKE INSIDE THE PATIENT´S SHOULDER. THE BROKEN PIECES WERE COMPLETELY 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24700911 ↗
• MalfunctionDec 29, 2025Difficult to Open or Close; Difficult to Open or Close

  ADDITIONAL INFORMATION PROVIDED: IT WAS FURTHER REPORTED THAT THIS OCCURRED AT THE END OF A PROCEDURE WITH NO PATIENT HARM OR CASE DELAY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23907325 ↗
• MalfunctionApr 10, 2024Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE AR-13998 WAS RECEIVED HAVING ¿FASTPASS SCORPION SL¿ ETCHED ON THE TOP OF THE HANDLE INSTEAD OF ¿LABRAL SCORPION¿ AS PREVIOUSLY SEEN ON OLDER DEVICES.

  Patient problems: Insufficient Information

  MAUDE report 19079196 ↗
• MalfunctionFeb 16, 2023Break

  IT WAS REPORTED THAT WHEN THE LABRAL SCORPION WAS USED FOR THE FIRST TIME THE TOP JAW BROKE OFF INSIDE THE PATIENT INTO TWO PIECES DURING FIRING AND SEPARATED IT FROM THE REST OF THE HANDLE. THE BROKEN PIECES WERE RETRIEVED FROM PATIENT. THIS OCCURRED DURING A SHOULDER ARTHROSCOPY, ANTERIOR STABILIZATION AND BICEPS TENODESIS SURGERY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A SHOULDER LASSO USED FOR SUTURE PASSING, WHICH REQUIRED A CHANGE IN THE SURGICAL TECHNIQUE. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16386055 ↗