Arthrex® AR-13997MFFRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888867293496), received between May 26, 2024 and May 14, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGERY THE TIP OF THE DEVICE DETACHED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25174370 ↗
• MalfunctionJan 26, 2026Break

  IT WAS REPORTED THAT DURING A SHOULDER SPEEDBRIDGE SURGERY WHILE ATTEMPTING TO PERFORM THE SUTURE WITH THE CLAMP, THE UPPER MOVING JAW BROKE AND ANOTHER CLAMP HAD TO BE USED TO COMPLETE THE SURGERY. 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 24176815 ↗
• MalfunctionJan 26, 2026Break

  IT WAS REPORTED THAT DURING A SHOULDER SPEEDBRIDGE SURGERY WHILE ATTEMPTING TO PERFORM THE SUTURE WITH THE CLAMP, THE UPPER MOVING JAW BROKE AND ANOTHER CLAMP HAD TO BE USED TO COMPLETE THE SURGERY. 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 24176692 ↗
• MalfunctionOct 23, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY USING SPEEDBRIDGE THE SCORPION DID NOT CLOSE AND THE SURGEON WAS UNABLE TO COMPLETE THE SUTURE. 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 23369723 ↗
• MalfunctionOct 23, 2025Break; Difficult to Open or Close; Break; Difficult to Open or Close

  ADDITIONAL INFORMATION: DURING THE VISUAL INSPECTION OF THE GOODS UPON RECEIPT, IT WAS IDENTIFIED THAT PART OF THE UPPER, MOVABLE JAW WAS BROKEN OFF. IT WAS CONFIRMED THAT NO PART OF THE DEVICE BROKE DURING THE SURGERY. THE DAMAGE DIDN`T OCCUR DURING A SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23366822 ↗
• MalfunctionOct 23, 2025Break; Difficult to Open or Close; Break; Difficult to Open or Close

  ADDITIONAL INFORMATION: DURING THE VISUAL INSPECTION OF THE GOODS UPON RECEIPT, IT WAS IDENTIFIED THAT PART OF THE UPPER, MOVABLE JAW WAS BROKEN OFF. IT WAS CONFIRMED THAT NO PART OF THE DEVICE BROKE DURING THE SURGERY. THE DAMAGE DIDN`T OCCUR DURING A SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23366724 ↗
• MalfunctionOct 23, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY USING SPEEDBRIDGE THE SCORPION DID NOT CLOSE AND THE SURGEON WAS UNABLE TO COMPLETE THE SUTURE. 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 23366648 ↗
• MalfunctionOct 17, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE SCORPION BROKE INSIDE THE PATIENT AND IT WAS NOT POSSIBLE TO GRASP THE SUTURE. ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (AR-13991N). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE CMACKENBACH 16-OCT-25 IT WAS COMFIRMED PER COMPLAINT REPORTER THAT THE NEEDLE DID NOT BREAK. ONLY THE SCORPION BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23322874 ↗
• MalfunctionSep 2, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER SURGERY THE TIP BROKE. ALL PARTS WERE RETRIEVED. 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 22946011 ↗
• MalfunctionMay 26, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE SURGEON IS NOT ABLE TO BRING THE THREAD THROUGH THE TISSUE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. 16-MAY-2023 UPDATE. FURTHER INFORMATION WERE PROVIDED THAT THE REPORTED EVENT OCCURRED DURING A SHOULDER SURGERY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19398857 ↗