MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-15 for SYNTHES MILLING DRILL BIT 03.820.167S manufactured by Synthes Inc..
[100159175]
Patient Sequence No: 1, Text Type: N, H10
[100159176]
Intra-operative a drill bit broke off in the operative site. Surgeon aware; able to retrieved the broken piece. Handed off the sterile field as one total component.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7272925 |
| MDR Report Key | 7272925 |
| Date Received | 2018-02-15 |
| Date of Report | 2018-02-13 |
| Date of Event | 2018-02-05 |
| Report Date | 2018-02-13 |
| Date Reported to FDA | 2018-02-13 |
| Date Reported to Mfgr | 2018-02-13 |
| Date Added to Maude | 2018-02-15 |
| 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 | SYNTHES MILLING DRILL BIT |
| Generic Name | BIT, SURGICAL |
| Product Code | GFG |
| Date Received | 2018-02-15 |
| Catalog Number | 03.820.167S |
| Lot Number | 7604645 |
| Device Expiration Date | 2019-03-31 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES INC. |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-15 |