ARTHRO-PIERCE 7209496Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010474513), received between Jan 10, 2018 and Mar 2, 2026 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Break

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, WHEN THE DOCTOR TRIED TO PASS AN ARTHROPIERCE STRAIGHT THROUGH THE TENDON, IT BROKE INSIDE THE PATIENT. THE BROKEN PIECE WAS REMOVED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24479950 ↗
• InjuryFeb 14, 2026Break

  IT WAS REPORTED THAT, DURING A LEFT SHOULDER ARTHROSCOPY WITH ROTATOR CUFF REPAIR PROCEDURE, THE ARTHROPIERCE BROKE AND THE TIP GOT LOST IN THE PATIENT. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24341291 ↗
• MalfunctionAug 26, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE ARTHROPIERCE CLAMP BROKE WHEN IT WAS REMOVED FROM THE JOINT. THE BROKEN PART WAS SEARCHED INTERNALLY AND EXTERNALLY ON THE PATIENT BUT WAS NOT FOUND. THE SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22901395 ↗
• MalfunctionJul 21, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE ARTHROPIERCE GOT BROKEN, THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SMITH AND NEPHEW BACKUP DEVICE WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22562201 ↗
• MalfunctionJul 20, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE TIP OF THE ARTHROPIERCE GOT BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22552268 ↗
• MalfunctionDec 2, 2024Break; Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, THE ARTHROPIERCE STRAIGHT TIP WAS FRACTURED. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20826495 ↗
• MalfunctionDec 7, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE TIP OF TWO (2) ARTHROPIERCE STRAIGHT BROKE INSIDE THE PATIENT'S JOINT. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A DELAY OF LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18283391 ↗
• InjuryMar 1, 2023Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER INSTABILITY PROCEDURE, THE ARTHROPIERCE STRAIGHT BRID FORCEPS BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED; HOWEVER, NO SURGICAL DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16464418 ↗
• MalfunctionJan 10, 2018Break

  IT WAS REPORTED THAT THE JAW BROKE DURING THE SURGERY NO PARTS WERE MISSING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7177701 ↗