MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-03-19 for RADIONICS DA (2.7)-D manufactured by Radionics, Inc..
[52654]
While drilling a twist drill hole to perform a stereotactic biopsy procedure, the drill bit snapped off approx 1 1/4 inch from the bottom of the fluted end. The piece of drill bit was removed with a straight clamp and curette. No pt injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219140-1997-00004 |
| MDR Report Key | 78974 |
| Report Source | 05 |
| Date Received | 1997-03-19 |
| Date of Report | 1997-03-19 |
| Date of Event | 1997-02-19 |
| Date Mfgr Received | 1997-02-19 |
| Date Added to Maude | 1997-03-31 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RADIONICS |
| Generic Name | DRILL |
| Product Code | HBG |
| Date Received | 1997-03-19 |
| Returned To Mfg | 1997-03-13 |
| Model Number | DA (2.7)-D |
| Catalog Number | DA (2.7)-D |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 78579 |
| Manufacturer | RADIONICS, INC. |
| Manufacturer Address | 22 TERRY AVE BRULINGTON MA 01803 US |
| Baseline Brand Name | RADIONICS |
| Baseline Generic Name | DRILL |
| Baseline Model No | DA (2.7)-D |
| Baseline Catalog No | DA (2.7)-D |
| Baseline ID | NONE |
| Baseline Device Family | DRILL ASSEMBLY |
| Baseline Shelf Life Contained | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-03-19 |