ARTHRO-PIERCE 72201186Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010605610), received between Apr 5, 2018 and Jan 7, 2026 — classified as 2 injuries, 5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2026Break; Material Deformation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE METAL PIECE OF ONE (1) ARTHROPIERCE INSTRUMENT BROKE WHEN IT PIERCED THROUGH THE ROTATOR CUFF. THE PIECE WAS REMOVED USING A GRASPER. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. THE PATIENT STATUS IS FINE. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23989258 ↗
• InjuryMay 4, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE ARTHROPIECE CLAMP WAS DAMAGED AT THE TIME OF PASSING THE POINTS OF THE SECOND SUTUREFIX ULTRA 1.9MM ANCHOR. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. THE TIP OF THE CLAMP REMAINED INSIDE THE PATIENT AND COULD NOT BE REMOVED. PATIENT CONDITION IS STABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14283742 ↗
• MalfunctionNov 1, 2020Difficult to Open or Close; Mechanical Jam; Difficult to Open or Close; Mechanical Jam

  IT WAS REPORTED THAT DURING ARTHROSCOPY, THE ARTHROPIERCE INSTRUMENT'S GRABBING ARM STOPPED CLOSING IN MID PROCEDURE. THERE WAS A DELAY OF UNDER 30 MIN, THE PROCEDURE WAS COMPLETED WITH A CHANGE IN TECHNIQUE USING A COMPETITOR DEVICE (MITEK CLEVERHOOK). NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

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

  MAUDE report 10767698 ↗
• InjuryOct 23, 2020Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE TIP OF THE ARTHROPIERCE INSTRUMENT CURVED LEFT BROKE WHEN IT WAS BEING PASSED THROUGH THE TISSUE. THE BROKEN TIP WAS REMOVED FROM THE PATIENT WITH A GRASPER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A ARTHROPIERCE INSTRUMENT CURVED RIGHT. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10726923 ↗
• MalfunctionSep 2, 2020Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE, THE ARTHRO-PIERCE INSTRUMENT CURVED LEFT BROKE. HOWEVER, THERE WAS NO BREAKAGE INSIDE THE PATIENT. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. HOWEVER, NO DELAY AND NO PATIENT COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10483381 ↗
• MalfunctionFeb 3, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SURGERY THE ARTHROPIERCE BROKE. IT IS UNKNOWN IF THERE WAS ANY BACKUP DEVICE AVAILABLE; THEREFORE, IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO DELAY, PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9662544 ↗
• MalfunctionApr 5, 2018Break

  IT WAS REPORTED DURING THE OPERATION, THE STITCHING PART OF THE INSTRUMENT WAS BROKEN. THE PROCEDURE AND TECHNIQUE WERE OBSERVED. THE FRAGMENT WAS REMOVED FROM THE PATIENT'S SOFT TISSUES AND DISPOSED OF. NO PATIENT INJURIES WERE REPORTED. NO SAMPLE AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7399229 ↗