| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | DRILL BIT | UNKNOWN | DEPUY SYNTHES POWER TOOLS | HXY | UNK_PRODUCT | UNKNOWN | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-09-15 | 0 |
Patient 1
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.
Patient 1
THIS IS EVENT 2 OF 2 OF THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING SURGERY FOR A TIBIAL DIAPHYSIS FRACTURE, IT WAS OBSERVED THAT SMOKE CAME OUT FROM THE PART OF THE RADIOLUCENT DRIVE DEVICE WHERE IT WAS SPINNING THE DRILL BIT DEVICE. ACCORDING TO THE REPORT, THE RADIOLUCENT DRIVE DEVICE AND THE DRILL BIT DEVICE STARTED RUNNING IDLE WHEN THE SURGEON TRIED TO PERFORM DISTAL LOCKING. THE SURGEON STATED THAT IT MIGHT HAVE BEEN DUE TO LOW POWER ON THE RADIOLUCENT DRIVE DEVICE WHICH CAUSED THAT DRILL BIT DEVICE TO NOT SPIN. THERE WAS A TEN MINUTE DELAY TO THE SURGICAL PROCEDURE. IT WAS UNKNOWN IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. 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.
Patient 1
DURING SUBSEQUENT FOLLOW-UP, THE REPORTED STATED THAT THE PROCEDURE WAS PERFORMED ON AN ELDERLY PERSON. IT WAS ALSO MENTIONED THAT THE DRILL DEVICE WAS NOT NEW AND THEREFORE DID NOT WORK SMOOTHLY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.