ARTHRO-PIERCE 7209499Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 03596010474544), received between Sep 1, 2017 and Mar 7, 2026 — classified as 5 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2026Break; Degraded; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE ARTHROPIERCE BROKE. THE PROCEDURE WAS RESUMED USING A SIMILAR S+N BACKUP. IT IS UNKNOWN WHETHER ANY DELAY OCCURRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24539926 ↗
• MalfunctionAug 27, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE ARTHROPIERCE FORCEPS BROKE INTO TWO PIECES, THE PIECES WERE REMOVED AND A SCOPE WAS USED TO MAKE SURE THAT THEY WERE COMPLETELY REMOVED. SURGERY WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20081885 ↗
• MalfunctionNov 20, 2023Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, WHEN THE ARTHROPIERCE WAS PASSED THROUGH THE TENDON, IT GOT TANGLED AND BROKE, ALL THE BROKEN PIECES WERE REMOVED USING A GRASPER. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A S+N BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18175854 ↗
• MalfunctionNov 1, 2023Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, WHEN USING THE ARTHROPIERCE 35 DEGREE DEVICE ON THE PATIENT'S TENDON, THE TIP BROKE. THE BROKEN TIP WAS REMOVED FROM THE PATIENT USING SUCTION FROM THE INFUSION AND ASPIRATION CANNULA. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING THE SAME REPORTED DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18051770 ↗
• MalfunctionMay 31, 2023Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY OPERATION, THE ARTHROPIERCE BROKE, HOWEVER, NO INDIVIDUAL PARTS BROKE OFF FROM IT. SURGERY WAS COMPLETED WITHOUT DELAY, USING A COMPETITOR DEVICE FROM STRYKER. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17031227 ↗
• MalfunctionMay 26, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE ARTHROPIERCE BROKE WHEN TRYING TO PASS IT THROUGH THE TENDON, IT FELL APART WHEN IT WAS REMOVED FROM INSIDE THE PATIENT'S CAVITY. SURGERY WAS COMPLETED WITHOUT DELAY, USING A BACK-UP DEVICE INSTEAD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17014623 ↗
• InjuryAug 22, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN PULLING THE THREAD, THE ARTHROPIERCE WAS STUCK IN THE TISSUE AND WHEN PULLED OUT IT BROKE. ALL THE PIECES WERE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15271812 ↗
• InjuryAug 16, 2022Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE ARTHRO-PIERCE 35 DEGREE UP BROKE WHEN THEY WERE GOING THROUGH THE TENDON AND PULLING THE ANCHOR THREAD. SURGERY WAS RESUMED, WITHOUT ANY DELAY WITH THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15234226 ↗
• InjuryMay 13, 2022Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE USING ARTHROPIERCE WHEN THE ANCHOR THREAD WAS PASSED IN THE LABRAL LESION, THE FORCEPS GOT DAMAGED AND WHEN THE SPECIALIST PULLED TO REMOVE THE FORCEPS IT BROKE IN 2 PARTS AND THE TIP WAS LOST AT THE TIME OF WASHING. IT WAS CONFIRMED THAT NO PIECES WERE LEFT IN THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO DELAY NOR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14399593 ↗
• InjuryMay 5, 2022Break; Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE ARTHROPIERCE BROKE INSIDE PATIENT. BROKEN PIECES WERE REMOVED FROM THE PATIENT USING TWEEZERS. THE PROCEDURE WAS COMPLETED WITHOUT DELAY BUT IT IS UNKNOWN HOW. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14290010 ↗
• MalfunctionMar 31, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE ARTHROPIERCE SYSTEM HAD A FAULTY OPENING ISSUE. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR'S DEVICE WITH A DELAY OF LESS THAN OR EQUAL TO 30 MIN. NO 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

  MAUDE report 11599550 ↗
• InjuryMar 19, 2021Break; Break

  IT WAS REPORTED THAT THE ARTHROPIERCE 35 DEGREE BROKE DURING SURGERY WHEN THE SOFT TISSUES WERE SUTURED IN THE SHOULDER. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR OTHER COMPLICATIONS. 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

  MAUDE report 11526978 ↗
• MalfunctionOct 4, 2018Break

  IT WAS REPORTED THAT THE DEVICE BROKE DURING A CASE. THE DEVICE BROKE OFF IN THE PATIENT AND THE PIECE WAS REMOVED. PROCEDURE COMPLETED WITH A COMPETITOR DEVICE. A DELAY OF 45 MINUTES WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7936281 ↗
• MalfunctionOct 4, 2018Material Twisted/Bent

  IT WAS REPORTED THAT THE DEVICE BENT DURING A PROCEDURE. THERE WAS A SURGICAL DELAY OF 45MIN AND THE PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7935326 ↗
• MalfunctionSep 25, 2018Material Deformation

  IT WAS REPORTED THAT THE DEVICE WAS BENT WHILE USING IT. NO PATIENT INJURIES WERE REPORTED. NO BACKUP WAS AVAILABLE FROM SMITH AND NEPHEW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7906751 ↗
• MalfunctionSep 1, 2017Break

  IT WAS REPORTED THAT THE DEVICE SNAPPED OFF DURING PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6839953 ↗