MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-10 for DS279729520 G0120 manufactured by Depuy Synthes.
[79399274]
Patient Sequence No: 1, Text Type: N, H10
[79399275]
The tip of the instrument detached and lodged itself inside a screw while tightening. The tip was retrieved and retained by the product rep.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6696879 |
| MDR Report Key | 6696879 |
| Date Received | 2017-07-10 |
| Date of Report | 2017-06-22 |
| Date of Event | 2017-06-19 |
| Report Date | 2017-06-22 |
| Date Reported to FDA | 2017-06-22 |
| Date Reported to Mfgr | 2017-06-22 |
| Date Added to Maude | 2017-07-10 |
| 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 |
| 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 |
| Generic Name | HANDLE, ORTHOPEDIC |
| Product Code | GDZ |
| Date Received | 2017-07-10 |
| Model Number | DS279729520 G0120 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-10 |