MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-03-09 for SMITH NEPHEW RICHARD * 7136-9007 manufactured by Smith Nephew Richard.
[377931]
Cement removal instrument was screwed into distal end of cement of hip. Instrument broke off approx 1 to 1 1/2 inches from the end. Another incision had to be made and window the femur to remove the piece of broken instrument.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1034900 |
| MDR Report Key | 581671 |
| Date Received | 2005-03-09 |
| Date of Report | 2005-02-14 |
| Date of Event | 2004-02-08 |
| Date Added to Maude | 2005-03-17 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMITH NEPHEW RICHARD |
| Generic Name | CEMENT REMOVAL INSTRUMENT 7MM - TAP |
| Product Code | LZV |
| Date Received | 2005-03-09 |
| Model Number | * |
| Catalog Number | 7136-9007 |
| Lot Number | 03KM04934 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 571524 |
| Manufacturer | SMITH NEPHEW RICHARD |
| Manufacturer Address | * MEMPHIS TN 38116 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-03-09 |