MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2005-08-29 for ARTHROSCOPIC SAW TOOTH DRILL GUIDE 214562 manufactured by Depuy Mitek.
[464218]
During a procedure, the surgeon noticed that there were metal particles coming from a brand new drill & drill guide. The metal particles remained in the patient. The surgeon is reporting no patient problems.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2005-00152 |
| MDR Report Key | 706789 |
| Report Source | 01,05,06,07 |
| Date Received | 2005-08-29 |
| Date of Report | 2005-08-24 |
| Date of Event | 2005-07-20 |
| Date Facility Aware | 2005-07-20 |
| Date Mfgr Received | 2005-07-20 |
| Date Added to Maude | 2006-05-03 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ARTHUR FRIGAULT |
| Manufacturer Street | 60 GLACIER DRIVE |
| Manufacturer City | WESTWOOD MA 02090 |
| Manufacturer Country | US |
| Manufacturer Postal | 02090 |
| Manufacturer Phone | 7812512756 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTHROSCOPIC SAW TOOTH DRILL GUIDE |
| Generic Name | ARTHROSCOPIC INSTRUMENT |
| Product Code | HXY |
| Date Received | 2005-08-29 |
| Model Number | 214562 |
| Catalog Number | 214562 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 695851 |
| Manufacturer | DEPUY MITEK |
| Manufacturer Address | 60 GLACIER DR WESTWOOD * |
| Baseline Brand Name | ARTHROSCOPIC SLOTTED DRILL GUIDE, S.T. |
| Baseline Generic Name | GUIDE, DRILL |
| Baseline Model No | * |
| Baseline Catalog No | 214562 |
| Baseline ID | * |
| Baseline Device Family | DRILL GUIDE |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-08-29 |