REPROCESSED ARTHROSCOPIC SHAVER
Received Dec 1, 2016 · Event occurred Oct 20, 2016
Report 3032391-2016-00043 · MDR key 6140280
Device
Product problems
- Material Fragmentation
- Material Fragmentation
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE IN QUESTION WAS RETURNED TO MEDLINE RENEWAL FOR EVALUATION. WE CONFIRMED THAT THE DEVICE WAS REPROCESSED AND THE REPORTED ISSUE WAS CONFIRMED. OUR INVESTIGATION INCLUDED BOTH AN INSPECTION OF THE RETURNED DEVICE, AND A REVIEW OF THE DEVICE HISTORY RECORD (DHR). WE RECONFIRMED THAT ALL PROCESSES WERE CONDUCTED AS REQUIRED, AND THAT THE DEVICE MET INSPECTION AND PROCESSING REQUIREMENTS PRIOR TO PACKAGING AND RELEASE. UNFORTUNATELY, THE ROOT CAUSE OF THE DEVICE FAILURE IS UNKNOWN AT THIS TIME. THE TIP WAS RETRIEVED BY THE SURGEON, HOWEVER THE PROCEDURE WAS DELAYED APPROXIMATELY 10 MINUTES IN ORDER TO OBTAIN ANOTHER DEVICE. THERE WAS NO ADDITIONAL MEDICAL INTERVENTION OR ADVERSE PATIENT CONSEQUENCE RELATED TO THE INITIAL REPORTED ISSUE. HOWEVER, DUE TO THE DELAY IN THE PROCEDURE, MEDLINE RENEWAL IS FILING THIS MEDWATCH REPORT IN AN ABUNDANCE OF CAUTION.
Description of Event or Problem
THE TIP OF A REPROCESSED DYONICS INCISOR PLUS BLADE DETACHED FROM THE SHAFT AND FELL INTO THE PATIENT'S SHOULDER DURING USE. THE TIP WAS RETRIEVED BY THE SURGEON.