MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-15 for N/A 310.23 manufactured by Stryker Sustainability Solutions Lakeland.
[111195802]
Patient Sequence No: 1, Text Type: N, H10
[111195804]
Synthes 2. 5 mm drill bit broke into two pieces, one remaining contained in the right ankle surgical site. Read free of any other metal fragments. Operating room team aware of events.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7605243 |
| MDR Report Key | 7605243 |
| Date Received | 2018-06-15 |
| Date of Report | 2018-06-05 |
| Date of Event | 2018-06-01 |
| Report Date | 2018-06-05 |
| Date Reported to FDA | 2018-06-05 |
| Date Reported to Mfgr | 2018-06-05 |
| Date Added to Maude | 2018-06-15 |
| 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 |
| Brand Name | N/A |
| Generic Name | BIT, SURGICAL |
| Product Code | GFG |
| Date Received | 2018-06-15 |
| Model Number | N/A |
| Catalog Number | 310.23 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER SUSTAINABILITY SOLUTIONS LAKELAND |
| Manufacturer Address | 5300 REGION COURT LAKELAND FL 33815 US 33815 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-15 |