KNEE ARTHROSCOPY PACK
Received Nov 27, 2023 · Event occurred Nov 2, 2023
Report 1423395-2023-00075 · MDR key 18210848
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
Patient
Unknown
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Description of Event or Problem
ACCORDING TO THE FACILITY "THE #11 SURGICAL BLADE THAT WAS USED BROKE APART DURING INCISION".
Additional Manufacturer Narrative
ACCORDING TO THE FACILITY "THE #11 SURGICAL BLADE THAT WAS USED BROKE APART DURING INCISION". PER THE FACILITY "WHEN ATTEMPTING TO RETRIEVE THE BROKE PIECE, THE REMNANTS BROKE AGAIN AND WERE SUCCESSFULLY REMOVED FROM THE PATIENT". NO ADDITIONAL INFORMATION IS AVAILABLE. THE SAMPLE WAS REQUESTED FOR EVALUATION. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.