DYONICS

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE REPROCESSED DYONICS FULL RADIUS BLADE (YELLOW) 4.5MM BROKE WHILE IN USE. PER REPORT, METAL SHAVINGS WERE NOTICED IN THE SURGICAL SITE AND THIS AREA WAS IRRIGATED UNTIL CLEAR. THERE WAS NO REPORT OF A SERIOUS INJURY, AN ADVERSE PATIENT CONSEQUENCE OR PROLONGED ANESTHESIA RELATED TO THIS INCIDENT. DUE TO THE REPORTED EVENT AND REQUIRED MEDICAL INTERVENTION TO RETRIEVE THE METAL SHAVINGS FROM THE SURGICAL SITE, THIS MEDWATCH IS BEING FILED. THE DEVICE IN QUESTION IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. THE LOT NUMBER ASSOCIATED WITH THE DEVICE WAS NOT PROVIDED. 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 THE REPROCESSED DYONICS FULL RADIUS BLADE BROKE WHILE IN USE AND METAL SHAVINGS WERE NOTED IN THE SURGICAL SITE.

Additional Manufacturer Narrative

MEDLINE RENEWAL RECEIVED THE DEVICE INVOLVED IN THIS INCIDENT LAST 04/04/2019. THE COMPLAINT OF A BROKEN REPROCESSED DYONICS FULL RADIUS BLADE WAS CONFIRMED. UPON INSPECTION OF THE RECEIVED DEVICE, IT WAS OBSERVED THAT THE OUTER HUB WAS CRACKED WHERE THE OUTER SHAFT CONNECTS TO THE HUB BASE, CAUSING THE SHAVER TO COME APART. A POTENTIAL ROOT CAUSE OF THIS DEVICE FAILURE IS SIDE FORCE BEING APPLIED TO THE SHAVER DURING USE. A DEFINITIVE ROOT CAUSE FOR THIS SPECIFIC DEVICE FAILURE COULD NOT BE DETERMINED AT THIS TIME. REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR LOT NUMBER 385821 AND THIS INDICATED THAT ALL PROCESSES WERE CONDUCTED AS REQUIRED AT THE TIME THE LOTS WERE PROCESSED. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.