MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-31 for 314.02 manufactured by Synthes - A-o.
[1530]
Handle of screwdriver broke into several pieces while physician was removing screws for broken plateinvalid data - regarding single use labeling of device. Patient medical status prior to event: unknown. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, other. Results of evaluation: component failure. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device permanently removed from service, other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4693 |
| MDR Report Key | 4693 |
| Date Received | 1992-07-31 |
| Date of Report | 1991-12-17 |
| Date of Event | 1991-12-05 |
| Date Facility Aware | 1991-12-05 |
| Report Date | 1991-12-17 |
| Date Reported to FDA | 1991-12-17 |
| Date Reported to Mfgr | 1991-12-05 |
| Date Added to Maude | 1993-06-02 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | SCREWDRIVER HANDLE |
| Product Code | LRZ |
| Date Received | 1992-07-31 |
| Model Number | 314.02 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | * |
| Device Sequence No | 1 |
| Device Event Key | 4409 |
| Manufacturer | SYNTHES - A-O |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-07-31 |