DYONICS
Received Jul 23, 2019 · Event occurred Jun 21, 2019
Report 3032391-2019-00018 · MDR key 8818650
Device
Generic name
Acromioblaster Burr (brick Red) 5.5mm
Manufacturer
Medline RenewalCatalog number
7205669RH
Lot number
UNK
Product problems
- Activation, Positioning or Separation Problem
Patient
31 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT DURING A SHOULDER SCOPE, THE REPROCESSED DYONICS ACROMIOBLASTER BURR WAS DIFFICULT TO LOAD INTO THE HAND PIECE. IT WAS ADDED THAT ONCE THE DEVICE WAS SUCCESSFULLY LOADED, IT WAS DIFFICULT TO REMOVE. PER REPORT, PROCEDURE TIME WAS EXTENDED FOR AN EXTRA 20 MINUTES TO COMPLETE. THE PATIENT HAD TO BE ADMINISTERED ADDITIONAL ANESTHESIA RELATED TO THIS PROCEDURE TIME EXTENSION. GENERAL ANESTHESIA WAS USED AND THERE WAS NO REPORT OF ANY ADVERSE PATIENT CONSEQUENCE AND NO EFFECT ON THE PATIENT'S STABILITY AS A RESULT OF THE INCIDENT. DUE TO THE REPORTED EVENT, THIS MEDWATCH IS BEING FILED. A SAMPLE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. A DEFINITIVE ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED AT THIS TIME. THE LOT NUMBER FOR THE REPORTED DEVICE IS UNKNOWN. 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 ACROMIOBLASTER BURR WAS DIFFICULT TO LOAD INTO THE HAND PIECE. THE PROCEDURE WAS EXTENDED FOR 20 MINUTES AND PATIENT REQUIRED ADDITIONAL ANESTHESIA.