MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-11-23 for ZIMMER 00-5048-001-00 manufactured by Zimmer.
[20469214]
The versipower drill was mysteriously running by itself. When the drill would not switch off, the battery was removed and the kirschner wire became attached to the scrub-tech's glove, causing him to drop the handpiece. No injury was caused and the patient was put at no riskdevice not labeled for single use. 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. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 33160-1992-00010 |
| MDR Report Key | 2003 |
| Date Received | 1992-11-23 |
| Date of Report | 1992-11-23 |
| Date of Event | 1992-11-17 |
| Report Date | 1992-11-23 |
| Date Reported to FDA | 1992-11-23 |
| Date Reported to Mfgr | 1992-11-23 |
| Date Added to Maude | 1993-01-05 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | UNKNOWN |
| 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 | ZIMMER |
| Generic Name | VERSIPOWER DRILL |
| Product Code | HBD |
| Date Received | 1992-11-23 |
| Catalog Number | 00-5048-001-00 |
| Lot Number | UNKNOWN |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Age | 01-AUG-90 |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 1862 |
| Manufacturer | ZIMMER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-11-23 |