FDA Adverse Event
Injury
Summary report: N
CANNULATED SCREWDRIVER
MDR report key: 58912
·
Received December 26, 1996
Report
- Report Number
- 1825034-1996-00042
- Event Type
- Injury
- Date Received
- December 26, 1996
- Date of Event
- November 21, 1996
- Report Date
- December 26, 1996
- Manufacturer
- ARTHROTEK/BIOMET, INC.
- Product Code
- HXX
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
CANNULATED SCREWDRIVER TIP BROKE DURING SCREW INSERTION. AN ARTHROTOMY WAS REQUIRED TO REMOVE THE TIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CANNULATED SCREWDRIVER | SCREWDRIVER, INSTRUMENT | HXX | ARTHROTEK/BIOMET, INC. | NA | 826460 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Hospitalization| R |