Arthrex® AR-13991N-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867283978), received between Jun 26, 2019 and Apr 27, 2026 — classified as 1 injury, 4 malfunctions.

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 18, 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.

• MalfunctionApr 27, 2026Break

  IT WAS REPORTED THAT DURING A SURGERY, THE NEEDLE BROKE OFF. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25000335 ↗
• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT DURING THE LABRUM REFIXATION, THE NEEDLE 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 24700491 ↗
• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT DURING THE LABRUM REFIXATION, THE NEEDLE 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 24700010 ↗
• MalfunctionJun 21, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE TIP OF THE DEVICE BROKE OFF. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 19580023 ↗
• InjuryJun 26, 2019Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF NEEDLE BROKE-OFF DURING A ROTATOR CUFF SHOULDER PROCEDURE. NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY WAS REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE. ON 03-JUN-2019 UPDATE: BROKEN TIP OF NEEDLE WAS NOT RETRIEVED FROM PATIENT. IT REMAINS IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 8735883 ↗