FDA Adverse Event
Injury
Summary report: N
3.5MM HEXAGONAL SCREWDRIVE WITH T-HANDLE
MDR report key: 2041925
·
Received March 29, 2011
Report
- Report Number
- 8030965-2011-00120
- Event Type
- Injury
- Date Received
- March 29, 2011
- Date of Event
- March 10, 2011
- Report Date
- March 11, 2011
- Manufacturer
- SYNTHES GMBH
- Product Code
- HXX
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS INFORMATION WAS NOT PROVIDED DURING INITIAL REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SUBJECT DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED. INVESTIGATION IS ON GOING; CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING DATE WITHOUT A LOT NUMBER.
Description of Event or Problem · 1
THE TIP OF THE HEXAGONAL SCREWDRIVER BROKE OFF AND COULD NOT BE REMOVED. THE TIP REMAINS IN THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3.5MM HEXAGONAL SCREWDRIVE WITH T-HANDLE | HEXAGONAL SCREWDRIVER | HXX | SYNTHES GMBH | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention |