ARTHRO-PIERCE 72201187Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010605627), received between Nov 1, 2021 and Jun 30, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A SHOULDER INSTABILITY ARTHROSCOPY, THE ARTHROPIERCE INSTRUMENT CURVED RIGHT BROKE INSIDE THE JOINT, AN X-RAY WAS USED TO LOCATE THE BROKEN PART THAT REMAINED IN THE JOINT. IT WAS NECESSARY TO MAKE A LARGER INCISION TO FIND THE BROKEN PIECE. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT USING A GRASPER AND AN ARTHROSCOPY WAS PERFORMED TO VISUALIZE BETTER. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A DELAY GREATER THAN 30 MINUTES.

  Patient problems: Laceration(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 22354429 ↗
• InjuryJan 17, 2022Break; Break

  IT WAS REPORTED THAT, DURING SHOULDER CAP SURGERY, INTERNAL TO THE PATIENT, THE HEAD OF THE ARTHRO-PIERCE WAS BROKEN. THE PIECES WERE REMOVED WITH TWEEZERS. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13267931 ↗
• InjuryNov 1, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SHOULDER REPAIR SURGERY, THE CLEVERHOOK TIP OF THE ARTHROPIERCE INSTRUMENT BECAME DISLODGED AND SUBSEQUENTLY EMBEDDED IN TENDON OF PATIENT. IT WAS CONSIDERED TO LEAVE THE TIP INSIDE THE JOINT BECAUSE IF THE TIP IS REMOVED IT COULD CAUSE FURTHER HARM TO THE PATIENT DUE TO A POSSIBLE NEED FOR TENDON DISSECTION. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12729416 ↗