UNKNOWN

Additional Manufacturer Narrative

THE LOT/SERIAL NUMBER AND MANUFACTURING LOCATION ARE UNKNOWN. DEVICE MANUFACTURE DATE: THE DEVICE MANUFACTURE DATE IS UNAVAILABLE. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE TIP OF AN UNKNOWN BURR DEVICE BROKE OFF INSIDE THE ANGLE DRIVER DEVICE. THE REPORTER STATED THAT THE BURR HAS NOT BEEN COMPLETELY REMOVED FROM THE DEVICE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

Additional Manufacturer Narrative

THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION WAS PERFORMED BASED ON THE OTHER TWO DEVICES THAT WERE RETURNED. IT WAS DETERMINED THAT THE TIP OF THE BROKE BURR DEVICE WAS FOUND INSIDE OF THE RETURNED ATTACHMENT DEVICE. IT WAS DETERMINED THAT THE PIECE OF THE BROKEN BURR DEVICE WAS THE LOWER PART OF THE DEVICE AND WAS APPROXIMATELY 1 1/2" LONG. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. IT WAS DETERMINED THAT THIS WAS INDICATIVE OF APPLYING TO MUCH FORCE ON THE CUTTER WHILE IN USE THUS COMPROMISING INTERNAL COMPONENTS OF THE ATTACHMENT DEVICE. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE MISUSE, ABUSE AND/OR ERROR. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.