MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-06-09 for ANCHOR NONE 1834-5D manufactured by Baxter Surgical.
[18333333]
Very small piece, 1mm, tip of needle broken off, rotator cuff repair, not found. Physician to take x-rays in office 5/20/92. In area that will not cause problem nor migrate. Manufacture representative notified, russ browndevice 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. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: yes. Corrective actions: other. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 686 |
| MDR Report Key | 686 |
| Date Received | 1992-06-09 |
| Date of Report | 1992-05-21 |
| Date of Event | 1992-05-14 |
| Date Facility Aware | 1992-05-14 |
| Report Date | 1992-05-21 |
| Date Reported to FDA | 1992-05-21 |
| Date Reported to Mfgr | 1992-05-14 |
| Date Added to Maude | 1992-06-12 |
| 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 |
| Brand Name | ANCHOR |
| Generic Name | REGULAR SURGEONS 1/2 CIRCLE CUTTING EDGE |
| Product Code | EJX |
| Date Received | 1992-06-09 |
| Model Number | NONE |
| Catalog Number | 1834-5D |
| Lot Number | C53AN |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 673 |
| Manufacturer | BAXTER SURGICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-06-09 |