FDA Adverse Event
Injury
Summary report: N
DEPTH GUAGE SCREW
MDR report key: 3174653
·
Received June 12, 2013
Report
- Report Number
- MW5030547
- Event Type
- Injury
- Date Received
- June 12, 2013
- Date of Event
- May 18, 2013
- Report Date
- June 12, 2013
- Manufacturer
- SYNTHES INC
- Product Code
- HWC
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DURING PLACEMENT OF THE MEDIAL PLATE A SHAFT SCREW WAS APPLIED WHICH WAS APPROXIMATELY A CENTIMETER TOO LONG. A LONG SCREW WAS PLACED ATTRIBUTABLE TO A DEPTH GAUGE WHICH WAS ASSEMBLED INAPPROPRIATELY. PT SUSTAINED A RADIAL NERVE INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 265930 | DEPTH GUAGE SCREW | GUAGE SCREW | HWC | SYNTHES INC | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Disability |