FDA Adverse Event
Other
Summary report: N
SYNTHES HEXAGONAL SCREWDRIVER
MDR report key: 58829
·
Received December 23, 1996
Report
- Report Number
- 2530088-1996-00007
- Event Type
- Other
- Date Received
- December 23, 1996
- Date of Event
- December 2, 1996
- Report Date
- December 20, 1996
- Manufacturer
- SYNTHES USA
- Product Code
- HXX
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
SCREW DRIVER TIP BROKE IN IMPLANT DURING SURGERY. TIP OF SCREW DRIVER REMAINS IN END CAP (IMPLANT).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNTHES HEXAGONAL SCREWDRIVER | SCREWDRIVER | HXX | SYNTHES USA | NA | A4FL643 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other | 459.012=END CAP (IMPLANT) |