MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-17 for FLEXIBLE DRILL 9203-4125 manufactured by United Orthopedic Corporation.
[184179354]
During left hip arthroplasty the flexible drill bit broke. No adverse pt event. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093806 |
| MDR Report Key | 9847827 |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-03-12 |
| Date Added to Maude | 2020-03-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXIBLE DRILL |
| Generic Name | BIT, DRILL |
| Product Code | HTW |
| Date Received | 2020-03-17 |
| Catalog Number | 9203-4125 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNITED ORTHOPEDIC CORPORATION |
| Manufacturer Address | IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-17 |