RAP-PAC 72202797Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556541289), received between Feb 28, 2018 and Dec 7, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 7, 2018Break

  IT WAS REPORTED THAT THE GUARD WIRE BROKE INSIDE THE PATIENT AND COULD NOT BE REMOVED. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO DELAYS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8141195 ↗
• MalfunctionFeb 28, 2018Break; Sticking

  IT WAS REPORTED THAT IT WAS USED A 1.2MM GUIDE WIRE TO GUIDE THE BIORCI SCREW AND ONCE SCREW WAS IMPLANTED HE TRIED TO REMOVE GUIDEWIRE THAT APPEARED TO BE STUCK. GUIDEWIRE BROKE LEAVING PART OF WIRE IN THE BONE. IT WAS TOOK AN X-RAY POST OPERATION AND IT WAS SAW THAT APPROX. 5MM WAS IN THE BONE. IT WAS LEFT IN THE PATIENT AS IS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7303180 ↗