FDA Adverse Event
Injury
Summary report: N
CANNULATED SCREWDRIVER ASNIS III HEX 5.0MM ELASTO
MDR report key: 1993492
·
Received February 8, 2011
Report
- Report Number
- 8031020-2011-00036
- Event Type
- Injury
- Date Received
- February 8, 2011
- Date of Event
- January 26, 2011
- Report Date
- January 27, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- HWC
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO HAS BEEN REQUESTED AND RECEIVED WILL BE SUBMITTED ON A SUPPLEMENTAL REPORT. SAME PT EVENT AS MDR 8031020-2011-00035.
Description of Event or Problem · 1
DURING SURGERY, THE SCREW HEAD BROKE WHEN THE SURGEON WAS ABOUT TO REMOVE IT WITH THE SCREW DRIVER. THEREFORE, THE SURGEON INSERTED IT IN THE SCREW HEAD BY USING THE EXTRACTOR. THE TIP OF EXTRACTOR BROKE WHEN THE EXTRACTOR WERE TIGHTENED. THEREFORE, THE SURGEON GOUGE THE BONE AROUND THE SCREW, AND PULLED OUT THE SCREW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CANNULATED SCREWDRIVER ASNIS III HEX 5.0MM ELASTO | INSTRUMENT | HWC | STRYKER OSTEOSYNTHESIS SELZACH | NA | P19482 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR | Required Intervention |