MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-19 for TWIST DRILL STANDARD KM166-00-00 manufactured by Brasseler Usa.
[80816966]
Pt had surgical repair of ruptured quadriceps tendon left side. A 1/16 drill bit broke off in the pt's patella during the surgical procedure. The broken bit was retrieved in its entirety during this surgical procedure. No harm to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071135 |
| MDR Report Key | 6732394 |
| Date Received | 2017-07-19 |
| Date of Report | 2017-07-19 |
| Date of Event | 2017-07-17 |
| Date Added to Maude | 2017-07-21 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Brand Name | TWIST DRILL STANDARD |
| Generic Name | TWIST DRILL-STANDARD 1/16" |
| Product Code | DZA |
| Date Received | 2017-07-19 |
| Catalog Number | KM166-00-00 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRASSELER USA |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2017-07-19 |