MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-10-18 for * manufactured by Synthes.
[20957423]
During total hip replacement, a piece of metal broke off the mallet being used. The metal was retrieved. There was no harm to the patient. The physician has not experienced this type of problem with this mallet in the past.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1904025 |
| MDR Report Key | 1904025 |
| Date Received | 2010-10-18 |
| Date of Report | 2010-10-18 |
| Date of Event | 2010-10-04 |
| Report Date | 2010-10-18 |
| Date Reported to FDA | 2010-10-18 |
| Date Added to Maude | 2010-11-21 |
| 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 | * |
| Generic Name | MALLET, ORTHOPEDIC |
| Product Code | HXL |
| Date Received | 2010-10-18 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES |
| Manufacturer Address | 1051-1101 SYNTHES AVE. MONUMENT CO 80132 US 80132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-10-18 |