MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-08-17 for CURETTE EXTRACTION 10MM 15383 18 6020-12-000 manufactured by Depuy Orthopaedics, Inc..
[22104124]
Tip of instrument broke off during usage in surgery. Doctor was aware;he chose to leave the tip in the bone rather then try to retiieve it & ordered a post op x-ray in pacu. Doctor read the xray and stated the piece of instrument was in the bone and not free floating. No other treatment was necessary.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1449869 |
| MDR Report Key | 1449869 |
| Date Received | 2009-08-17 |
| Date of Report | 2009-08-17 |
| Date of Event | 2009-03-17 |
| Report Date | 2009-08-17 |
| Date Reported to FDA | 2009-08-17 |
| Date Added to Maude | 2009-08-26 |
| 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 | CURETTE EXTRACTION 10MM |
| Generic Name | CURETTE, BONE |
| Product Code | FZS |
| Date Received | 2009-08-17 |
| Model Number | 15383 |
| Catalog Number | 18 6020-12-000 |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Address | 700 ORTHOPEDIC DRIVE WARSAW IN 46581 US 46581 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-08-17 |