MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-11-10 for ACETABULAR TRIAL IMPACTOR UNK manufactured by Smith & Nephew Plc Ads.
[533901]
Gray plastic thread stop broke into 3 pieces during trial insertion. Device is used with a mallet to impact acetabular trial into acetabulum.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1040912 |
| MDR Report Key | 780833 |
| Date Received | 2006-11-10 |
| Date of Report | 2006-11-10 |
| Date of Event | 2006-11-03 |
| Date Added to Maude | 2006-11-16 |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACETABULAR TRIAL IMPACTOR |
| Generic Name | * |
| Product Code | KIL |
| Date Received | 2006-11-10 |
| Returned To Mfg | 2006-11-05 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 768612 |
| Manufacturer | SMITH & NEPHEW PLC ADS |
| Manufacturer Address | 15 ADAM ST LONDON * WC2N 6LA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-11-10 |