MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-06-07 for SYNTHES (FRA) * 397.013 manufactured by Synthes Usa.
[155925]
Synthes fra distracter blade was broken off during surgical procedure. Surgeon was present and operating faulty device during occurrence. X-ray was taken. An attempt to remove broken insturment was unsuccessful at this time. The pt will return for surgery one week from now for a posterior fusion at which time the broken instrument will be removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1016543 |
| MDR Report Key | 227725 |
| Date Received | 1999-06-07 |
| Date of Report | 1999-06-04 |
| Date of Event | 1999-06-04 |
| Date Added to Maude | 1999-06-21 |
| 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 | 0 |
| 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 | SYNTHES (FRA) |
| Generic Name | DISTARCTOR BLADE |
| Product Code | HTS |
| Date Received | 1999-06-07 |
| Model Number | * |
| Catalog Number | 397.013 |
| Lot Number | A7HA12 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 220830 |
| Manufacturer | SYNTHES USA |
| Manufacturer Address | 1690 RUSSELL RD PAOLI PA 19301 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-06-07 |