REPROCESSED ARTHROSCOPIC SHAVER
Received Feb 3, 2017
Report 3032391-2017-00002 · MDR key 6301703
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
WE RECEIVED A REPORT INDICATING THAT THE PIECE OF A REPROCESSED ARTHROSCOPIC SHAVER DISLODGED AND FELL INTO THE PATIENT DURING USE. THE PHYSICIAN WAS ABLE TO RETRIEVE THE BROKEN PIECE DURING THE PROCEDURE. NEITHER THE DEVICE IN QUESTION NOR THE LOT NUMBER WAS RETURNED TO FOR EVALUATION, THEREFORE WE COULD NOT CONFIRM IF THE DEVICE WAS REPROCESSED. ALTHOUGH MULTIPLE ATTEMPTS TO OBTAIN INFORMATION WERE MADE, DUE TO THE LACK OF INFORMATION SURROUNDING THE INCIDENT, WE DO NOT HAVE ENOUGH INFORMATION TO DETERMINE THE FAILURE MODE OR SUBSEQUENT ROOT CAUSE OF THE FAILURE. IF MORE INFORMATION IS PROVIDED THEN THIS MDR WILL BE UPDATED. THE USER DID NOT REPORT PATIENT HARM OR ADDITIONAL MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE INCIDENT. HOWEVER IN AN ABUNDANCE OF CAUTION, WE ARE FILING THIS MEDWATCH REPORT. DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem
WE RECEIVED A REPORT INDICATING THAT A PIECE OF A REPROCESSED ARTHROSCOPIC SHAVER DISLODGED AND FELL INTO THE PATIENT DURING USE.