MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-31 for 2.5MM DRILL BIT 310.25 manufactured by Synthes (usa) Products Llc.
[185707479]
During an orif of an ankle, a synthesis drill bit broke leaving a small piece of the drill in the patient's tibia bone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9902873 |
| MDR Report Key | 9902873 |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-03-07 |
| Report Date | 2020-03-17 |
| Date Reported to FDA | 2020-03-17 |
| Date Reported to Mfgr | 2020-03-31 |
| Date Added to Maude | 2020-03-31 |
| 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 | 2.5MM DRILL BIT |
| Generic Name | INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT |
| Product Code | HWE |
| Date Received | 2020-03-31 |
| Model Number | 310.25 |
| Catalog Number | 310.25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES (USA) PRODUCTS LLC |
| Manufacturer Address | 1303 GOSHEN PKWY WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |