MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-07-07 for * PRO6300 manufactured by Conmed Linvatec.
[900478]
Linvatec saw broke during total knee. The trigger fell off right into the field. Obtained the trigger and removed from field. Opened new saw to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1081379 |
| MDR Report Key | 1081379 |
| Date Received | 2008-07-07 |
| Date of Report | 2007-12-07 |
| Date of Event | 2007-11-29 |
| Report Date | 2007-12-07 |
| Date Reported to FDA | 2008-07-07 |
| Date Added to Maude | 2008-07-28 |
| 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 | SAW, SURGICAL, ORTHOPEDIC |
| Product Code | DZH |
| Date Received | 2008-07-07 |
| Returned To Mfg | 2007-11-30 |
| Model Number | PRO6300 |
| Catalog Number | PRO6300 |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 8 MO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 1047808 |
| Manufacturer | CONMED LINVATEC |
| Manufacturer Address | A DIVISION OF CONMED CORP. 11311 CONCEPT BLVD LARGO FL 33773 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-07-07 |