2.3MM DRILL GUIDE CANNULA
Received Mar 8, 2022 · Event occurred Feb 9, 2022
Report 3025141-2022-00046 · MDR key 13697644
Device
Generic name
Drill Guide
Manufacturer
Acumed, LlcModel number
80-0624Catalog number
80-0624
Lot number
UNKNOWN
Product problems
- Break
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
DURING THE PROCEDURE, AS THE SURGEON WAS DRILLING, THE DEVICE SNAPPED CLEANLY. IT WAS NOT CLEAR WHETHER THE CAUSE WAS THE BONE BEING DENSE OR IMPACT WITH K WIRES. DUE TO THE USAGE OF TARGETING GUIDE, THE SURGEON FELT IT WASN'T TRAJECTORY. THE SURGERY WAS COMPLETED SMOOTHLY FOLLOWING THIS ISSUE, BUT THE SURGEON HAD TO TAKE TIME ENSURING THERE WAS NO METAL LEFT WITHIN THE PATIENT. THIS REPORT IS RELATED TO REPORT NUMBER 3025141-2022-00045 ON THE DRILL USED IN THIS EVENT AND REPORT NUMBER 3025141-2022-00047 WHICH IS ON THE PLATE USED DURING THIS EVENT.
Additional Manufacturer Narrative
THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. MANUFACTURING AND INSPECTION RECORDS COULD NOT BE REVIEWED AS THE BATCH/LOT NUMBER IS UNKNOWN.