MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-04-05 for ZIMMER 00-4502-025-00 manufactured by Zimmer.
[2585]
Dr. Was tightening down the last of three screws into an acetabular cup shell when the tip of the screwdriver broke off in the head of the screw. It is unknown which screw it was but the three used are 1 each and 2 each. The dr. Attempted to remove the broken piece but could not get it out. He stated that if he could get it out and since the liner goes over it and fits flush, we'll leave it in. No serious illiness or serious injury reporteddevice 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. 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 | 32962-1993-00003 |
| MDR Report Key | 5982 |
| Date Received | 1993-04-05 |
| Date of Report | 1993-01-27 |
| Date of Event | 1993-01-25 |
| Date Facility Aware | 1993-01-25 |
| Report Date | 1993-01-27 |
| Date Reported to FDA | 1993-01-27 |
| Date Reported to Mfgr | 1993-01-25 |
| Date Added to Maude | 1993-07-30 |
| 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 | HEXHEAD SCREWDRIVER/UNIVERSAL JOINT 2.5MM DIA. |
| Product Code | LRZ |
| Date Received | 1993-04-05 |
| Catalog Number | 00-4502-025-00 |
| Lot Number | 68945000 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 5680 |
| Manufacturer | ZIMMER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-04-05 |