FDA Adverse Event
Malfunction
Summary report: N
MEDARTIS POWER SCREWDRIVER 2.5/2.8
MDR report key: 15446008
·
Received September 16, 2022
Report
- Report Number
- MW5112096
- Event Type
- Malfunction
- Date Received
- September 16, 2022
- Date of Event
- June 27, 2022
- Report Date
- September 14, 2022
- Manufacturer
- MEDARTIS INC.
- Product Code
- HWC
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
DURING A DISTAL RADIUS ORIF PROCEDURE A SCREWDRIVER TIP BROKE OFF THE END OF THE SCREWDRIVER, ALL PORTIONS RETRIEVED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2752302 | MEDARTIS POWER SCREWDRIVER 2.5/2.8 | SCREW, FIXATION, BONE | HWC | MEDARTIS INC. | A-2013 | 19194340 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Female |