inforMED
MalfunctionMOU

SURETAC RAPID DELIVERY SYSTEM W/O GLENOID GUIDE

Received Jun 23, 2006 · Event occurred May 17, 2006

Report 1219602-2006-00091 · MDR key 731948

Device

Generic name

Suretac Rapid Delivery

Model number

7209818

Catalog number

7209818

Lot number

UNK

Product problems

  • Break
  • Replace
  • Tip breakage

Patient

UNKNOWN

  • Surgery, prolonged
  • Foreign body, removal of
  • Laparotomy
  • Therapy/non-surgical treatment, additional

Narrative

Description of Event or Problem

SALES REP REPORTED THAT ONCE THE GUIDE PIN WAS REMOVED AFTER THE SURETAC WAS PLACED, IT WAS NOTICED THAT THE TIP OF THE PIN WAS BROKEN AND MISSING. X-RAY CONFIRMED THAT THE TIP WAS IN THE SURETAC, IN THE PT. SURGERY WAS CONVERTED TO AN OPEN-PROCEDURE IN ORDER TO REMOVE BOTH THE SURETAC AND THE BROKEN TIP. BANKART REPAIR WAS COMPLETED USING A COMPETITOR'S DEVICE. THE ISSUE CAUSED A ONE HOUR DELAY.

Additional Manufacturer Narrative

DEVICE IS NOT BEING RETURNED FOR EVALUATION THEREFORE, NO DETERMINATION COULD BE MADE FOR THE REPORTED DEVICE FAILURE.