MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-12-30 for CANNULATED SCREW DRIVER manufactured by Synthes (usa).
[1021]
Large ao cannulated screws being used in left hip. Screwdriver fragmented while in use. All fragments removed; confirmed by c-arm x-ray. Screwdriver returned to synthes for replacementdevice not labeled for single use. Patient medical status prior to event: unknown. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced:. Service provided by: manufacturer. Service records not available. No imminent hazard to public health claimed. Device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: actual device involved in incident was evaluated, none or unknown. Results of evaluation: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: yes. Corrective actions: device returned to manufacturer/dealer/distributor. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3595 |
| MDR Report Key | 3595 |
| Date Received | 1992-12-30 |
| Date of Report | 1992-11-30 |
| Date of Event | 1992-11-18 |
| Date Facility Aware | 1992-11-18 |
| Report Date | 1992-11-30 |
| Date Reported to FDA | 1992-11-30 |
| Date Added to Maude | 1993-04-26 |
| 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 | 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 | CANNULATED SCREW DRIVER |
| Product Code | LRZ |
| Date Received | 1992-12-30 |
| ID Number | PART NO. 314.19 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 3335 |
| Manufacturer | SYNTHES (USA) |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-12-30 |