MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-27 for UNKNOWN manufactured by Synthes (usa) Products Llc.
[115220608]
During this procedure, a drill bit was in use and was broken and left inside of the bone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7725930 |
| MDR Report Key | 7725930 |
| Date Received | 2018-07-27 |
| Date of Report | 2018-07-10 |
| Date of Event | 2018-07-03 |
| Report Date | 2018-07-10 |
| Date Reported to FDA | 2018-07-10 |
| Date Reported to Mfgr | 2018-07-27 |
| Date Added to Maude | 2018-07-27 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | UNKNOWN |
| Generic Name | BIT, SURGICAL |
| Product Code | GFG |
| Date Received | 2018-07-27 |
| Model Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES (USA) PRODUCTS LLC |
| Manufacturer Address | 1302 WRIGHTS LANE E. WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-07-27 |