DYONICS
Received Nov 4, 2019 · Event occurred Oct 21, 2019
Report 3032391-2019-00026 · MDR key 9273945
Device
Generic name
Full Radius Blade (yellow) 4.5mm
Manufacturer
Medline RenewalCatalog number
7205306RH
Lot number
387175
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE REPROCESSED DYONICS FULL RADIUS BLADE (YELLOW) 4.5MM BROKE OFF IN THE PATIENT. THE DEVICE PIECES WERE REPORTEDLY RETRIEVED FROM THE PATIENT THROUGH AN UNKNOWN METHOD. DUE TO THE REPORTED INCIDENT AND THE REQUIRED INTERVENTION TO RETRIEVE THE BROKEN DEVICE PIECES FROM THE PATIENT, THIS MEDWATCH IS BEING FILED. THE SAMPLE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND THIS INDICATED THAT ALL PROCESSES WERE CONDUCTED AS REQUIRED AT THE TIME THE LOT WAS PROCESSED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE REPROCESSED DYONICS FULL RADIUS BLADE BROKE OFF IN THE PATIENT.