ARTHRO-PIERCE 7209497Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 03596010474520), received between Feb 8, 2018 and Mar 30, 2026 — classified as 2 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, IT WAS EVIDENT THAT THE JAW OF THE ARTHROPIERCE WAS FRACTURED.THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24715432 ↗
• MalfunctionJul 3, 2025Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE TIP OF THE ARTHROPIERCE BROKE AND FELL INTO THE PATIENT. THE BROKEN PIECE WAS SUCCESSFULLY REMOVED WITH FORCEPS. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE, INSTEAD. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22391858 ↗
• MalfunctionFeb 21, 2025Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN THE ARTHROPIERCE WAS PASSED, IT BROKE. NO DAMAGE CAUSED, THE PATIENT'S HEALTH CONDITION IS STABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. EVERY PIECE WAS REMOVED FROM THE PATIENT USING A GRASPER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21437124 ↗
• MalfunctionFeb 21, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER INSTABILITY PROCEDURE THE ARTHROPIECE FORCEPS WERE BROKEN. THE PIECES WERE REMOVED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITH NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21433205 ↗
• MalfunctionFeb 6, 2025Break; Break

  IT WAS REPORTED THAT THE CLAMP OF THE ARTHROPIERCE BROKE, BUT IT IS UNKNOWN WHEN DURING THE SURGERY THE DEVICE FAILED. THE CLAMP WAS NOT SEARCHED FOR INSIDE THE PATIENT DUE TO THE UNCLEAR TIMING OF THE BREAKAGE. SURGERY WAS COMPLETED WITHOUT SURGICAL DELAY USING THE SAME DEVICE, AND NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21319315 ↗
• MalfunctionJan 20, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TIP OF THE ARTHROPIERCE WAS FRACTURED WHILE TRYING TO PASS THE TISSUE. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21191269 ↗
• MalfunctionOct 2, 2024Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE ARTHROPIERCE BROKE AT THE TIP. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT. IT IS UNKNOWN IF A BACK-UP DEVICE WAS AVAILABLE. NO DELAY OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20352591 ↗
• MalfunctionFeb 13, 2024Break; Break

  IT WAS REPORTED THAT DURING SET UP FOR AN ARTHROSCOPY, THE ARTHROPIERCE 45° RIGHT WAS FOUND DETACHED IN THE MIDDLE. IN ADDITION, A PART OF THE JAW BROKE OFF. THERE WAS NO SURGICAL DELAY REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18695437 ↗
• MalfunctionNov 22, 2023Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPY, THE ARTHROPIERCE´S TIP BROKE WHEN PASSING THROUGH THE PATIENT´S LABRAL LESION. THE PIECES WERE COMPLETELY REMOVED. THE PROCEDURE 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 18196270 ↗
• MalfunctionJun 6, 2023Break; Break

  IT WAS REPORTED, DURING AN ARTHROSCOPY, THE ARTHROPIERCE BROKE. ALL BROKEN PARTS WERE REMOVED FROM THE PATIENT USING ARTHROSCOPIC FORCEPS. SURGERY WAS COMPLETED WITHOUT DELAY, USING A CLEVERHOOK FROM DEPUY MITEK (COMPETITOR'S DEVICE). NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17072675 ↗
• InjuryMar 22, 2021Break; Break

  IT WAS REPORTED THAT DURING SURGERY, WHILE SUTURING THE SOFT TISSUES IN THE SHOULDER, THE SURGEON SAW THAT THE BRANCH OF THE ARTHROPIERCE DEVICE DID NOT LOCK. WHEN IT WAS REMOVED FROM THE JOINT, IT WAS NOTICED THAT THE JAMMED BRANCH BROKE OFF. 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 11547766 ↗
• MalfunctionMar 10, 2021Break; Break

  IT WAS REPORTED THAT THE TIP OF THE ARTHROPIERCE 45 RIGHT WAS BROKEN. NO CASE INVOLVED. 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 11456658 ↗
• InjuryJan 11, 2021Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN THE SOFT TISSUES WERE SUTURED IN THE SHOULDER, THE ARTHROPIERCE BROKE OFF. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11152615 ↗
• MalfunctionDec 4, 2020Break; Break

  IT WAS REPORTED THAT UPPER MOVABLE BRANCH OF THE ARTHRO-PIERCE WAS BROKEN. INCIDENT OCCURRED BEFORE THE PROCEDURE. THERE WAS NO DELAY AND A BACK-UP DEVICE WAS AVAILABLE. 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 10944440 ↗
• MalfunctionJan 7, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING INSTABILITY SURGERY THE TIP OF THE ARTHROPIERCE BROKE INSIDE THE PATIENT, BROKEN PIECES WERE REMOVED WITH FORCEPS AND SUCTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. 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 Known Impact Or Consequence To Patient

  MAUDE report 9560548 ↗
• MalfunctionMay 14, 2019Break

  IT WAS REPORTED THAT DURING PROCEDURE, THE TIP OF THE DEVICE WAS BROKEN OUTSIDE THE PATIENT AND NO DELAY OR PATIENT INJURIES WERE REPORTED. THE PROCEDURE WAS COMPLETED WITH THE COMPETITOR DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8608152 ↗
• MalfunctionMay 22, 2018Break; Detachment Of Device Component

  THE TIP OF THE ARTHROPIERCE BROKE OFF INSIDE THE JOINT WHILE TRYING TO PASS SUTURE DURING AN ARTHROSCOPIC LABRAL REPAIR. THERE WAS ABOUT AN HOUR DELAY. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7535469 ↗
• MalfunctionFeb 8, 2018Break

  IT WAS REPORTED THAT THE MOVABLE BITE BROKE INSIDE THE PATIENT. PIECE WAS RECOVERED. THERE WAS NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7252880 ↗