MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-05 for 310.23 31023 manufactured by Synthes (u.s.a.) Lp.
[177785754]
A 2. 5 drill bit broke while being used on the patient. It broke in two pieces, one piece is stuck in the patient's bone and the other was still attached to the power chuck. Surgeon decided to leave drill bit piece in the patient's bone. Flat plate taken , radiologist reported to surgeon his reading per policy. Other half of drill bit given to charge nurse.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9670699 |
| MDR Report Key | 9670699 |
| Date Received | 2020-02-05 |
| Date of Report | 2020-01-15 |
| Date of Event | 2020-01-11 |
| Report Date | 2020-01-15 |
| Date Reported to FDA | 2020-01-15 |
| Date Reported to Mfgr | 2020-02-05 |
| Date Added to Maude | 2020-02-05 |
| 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 | NA |
| Generic Name | INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED ACCESSORY/ATTACHMENT |
| Product Code | HSZ |
| Date Received | 2020-02-05 |
| Model Number | 310.23 |
| Catalog Number | 31023 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES (U.S.A.) LP |
| Manufacturer Address | 1210 WARD AVE WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-05 |