MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-24 for ROSA KNEE SYSTEM ROSAS 00082 manufactured by Orthofix, Inc..
[184723639]
Drill bit went easily through the drill adaptor guide tube and as soon as drilling started, the drill adaptor guide locked on the drill bit and would not move. A switch was made to second drill adaptor guide tube and same problem occurred after a few holes were drilled.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9873583 |
| MDR Report Key | 9873583 |
| Date Received | 2020-03-24 |
| Date of Report | 2020-02-15 |
| Date of Event | 2020-02-06 |
| Report Date | 2020-02-15 |
| Date Reported to FDA | 2020-02-15 |
| Date Reported to Mfgr | 2020-03-23 |
| Date Added to Maude | 2020-03-24 |
| 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 | 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 | ROSA KNEE SYSTEM |
| Generic Name | ORTHOPEDIC STEREOTAXIC INSTRUMENT |
| Product Code | OLO |
| Date Received | 2020-03-24 |
| Catalog Number | ROSAS 00082 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHOFIX, INC. |
| Manufacturer Address | 3451 PLANO PARKWAY LEWISVILLE TX 75056 US 75056 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-24 |