inforMED
MalfunctionHTE

PERIOSTEAL ELEVATOR 3MM CURVED BLADE - ROUND EDGE

Received Feb 4, 2019

Report 2939274-2019-56301 · MDR key 8302427

Device

Generic name

Elevator

Model number

399.481

Catalog number

399.481

Product problems

  • Contamination /Decontamination Problem
  • Contamination /Decontamination Problem

Patient

Not reported

  • No Patient Involvement
  • No Patient Involvement

Narrative

Additional Manufacturer Narrative

COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON JANUARY 15, 2019, A PERIOSTEAL ELEVATOR ROUND EDGE-CURVED BLADE AND A SMALL HEXAGONAL SCREWDRIVER WERE DISCOVERED TO HAVE CRACKED HANDLES AND STAINED POUCHES. THIS WAS DISCOVERED DURING STERILIZATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A PERIOSTEAL ELEVATOR 3MM CURVED BLADE - ROUND EDGE. THIS IS REPORT 1 OF 2 FOR (B)(4).