MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-05-24 for BIOMET * 31 473610 manufactured by Biomet, Inc..
[18966320]
The release mechanism of the broach handle snapped off.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 402032 |
| MDR Report Key | 402032 |
| Date Received | 2002-05-24 |
| Date of Event | 2002-04-13 |
| Date Reported to Mfgr | 2002-04-05 |
| Date Added to Maude | 2002-07-01 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOMET |
| Generic Name | BROACH HANDLE |
| Product Code | GAC |
| Date Received | 2002-05-24 |
| Model Number | * |
| Catalog Number | 31 473610 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 15 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 391057 |
| Manufacturer | BIOMET, INC. |
| Manufacturer Address | 56 EAST BELL DR. WARSAW IN 465810587 US |
| Baseline Brand Name | RASP HANDLE STYLE A |
| Baseline Generic Name | INSTRUMENT |
| Baseline Model No | NA |
| Baseline Catalog No | 31-473610 |
| Baseline ID | NA |
| Baseline Device Family | RASP HANDLE STYLE A |
| 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 | 2002-05-24 |