| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | LUPINE DRILL GUIDE | ARTHROSCOPIC INSTRUMENT | DEPUY MITEK | LXI | UNK | UNK | UNK | N | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2007-10-01 | 0 |
Patient 1
WE HAVE RECEIVED A GENRIC STATEMENT, "I HAVE SEEN THIS A FEW TIMES", ABOUT METAL SHAVINGS IN CONNECTION WITH THE USE OF UNNAMED DRILL GUIDES. THERE IS NO FURTHER INFORMATION AVAILABLE AND THERE WERE NO REPORTED PATIENT CONSEQUENCES. THIS IS ALL THAT IS KNOWN.
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. THIS 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. NOTHING IS BEING RETURNED AS THIS WAS A VAGUE AND GENERALIZED COMMUNICATION OF PROBABLE EVENTS. 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. OUTSIDE OF THIS AT THIS POINT IN TIME NO FURTHER ACTION IS WARRANTED.