MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2007-10-08 for LUPINE DRILL GUIDE UNK manufactured by Depuy Mitek.
[721082]
Our rep is reporting that during a shoulder repair, some metal shavings went into the pt's body while using a mitek lupine drill guide. All of the debris was suctioned from the body, and the case was concluded successfully without further incident or harm to the pt.
Patient Sequence No: 1, Text Type: D, B5
[7852673]
Nothing is being returned, discarded by the user facility. However, 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. 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221934-2007-00299 |
| MDR Report Key | 924173 |
| Report Source | 05,06,07 |
| Date Received | 2007-10-08 |
| Date of Report | 2007-09-28 |
| Date of Event | 2000-09-28 |
| Date Facility Aware | 2007-09-28 |
| Report Date | 2007-09-28 |
| Date Reported to Mfgr | 2007-09-28 |
| Date Mfgr Received | 2007-09-28 |
| Date Added to Maude | 2007-11-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | MR ARTHUR FRIGAULT |
| Manufacturer Street | 325 PARAMOUNT DR. |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 508977356 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUPINE DRILL GUIDE |
| Generic Name | ARTHROSCOPIC INSTRUMENT |
| Product Code | LXI |
| Date Received | 2007-10-08 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 910536 |
| Manufacturer | DEPUY MITEK |
| Manufacturer Address | 325 PARAMOUNT DR. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-10-08 |