| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | LUPINE FISH MOUTH DRILL GUIDE | ARTHROSCOPIC INSTRUMENT | DEPUY MITEK | LXI | 213817 | 213817 | 6F4 | N | N | Y |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2007-10-09 | 0 |
Patient 1
OUR SALES REP IS REPORTING THAT DURING AN ARTHROSCOPIC SHOULDER REPAIR, IT WAS NOTED THAT THERE WERE SOME METAL SHAVINGS THAT EMANATED FROM A LUPINE DRILL GUIDE INTO THE JOINT SPACE. ALL OF THE DEBRIS WAS SUCTIONED OUT, AND THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT.
Patient 1
WE BELIEVE THAT THIS TYPE OF EVENT IS MOST LIKELY TECHNIQUE RELATED, EXTENSIVE LAB TESTING HAS SHOWN THAT UNDER NORMAL CONDITIONS THE REPORTED EVENT MODE COULD NOT BE DUPLICATED, HOWEVER, UNDER EXTREME CONDITIONS, THAT IS WHEN THE DRILL GUIDE WAS BENT DURING DRILLING WITH A DRILL BIT, THIS CAUSED THE DRILL BIT TO RUB AGAINST INNER SURFACE OF THE BENT DRILL GUIDE CAUSING SOME METAL TO SHAVE OFF OF THE DRILL GUIDE, THE REPORTED CONDITION WAS THEN DUPLICATED. THE PHENOMENA HAS BEEN THE SUBJECT OF A LONG AND CONSIDERABLE STUDY. AT THIS POINT IN TIME ,THE ENGINEERING DESIGN AND THE QUALITY ENGINEERING TEAMS ARE IN THE MIDST OF DEVELOPING SOME DESIGN CHANGES TO SUBVERT, AND OR GREATLY REDUCE THIS TYPE OF EVENT. MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH, WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. WHEN AND IF THE COMPLAINT DEVICE IS RECEIVED HERE AT MITEK, IT WILL BE DISCARDED AS THE REPORTED PHENOMENA IS ACKNOWLEDGED, AND IS IN THE PROCESS OF BEING ADDRESSED.