FDA Adverse Event
Other
Summary report: N
SYNTHES 1.1MM DRILL BIT
MDR report key: 38367
·
Received September 13, 1996
Report
- Report Number
- 1719045-1996-00001
- Event Type
- Other
- Date Received
- September 13, 1996
- Date of Event
- August 10, 1996
- Report Date
- September 11, 1996
- Manufacturer
- SYNTHES USA
- Product Code
- HTW
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DURING CRANIOTOMY, DRILL BIT BROKE IN BONE OF PT. PORTION REMAINS IN PT. DR NOT CONCERNED REGARGING PORTION STILL IN PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNTHES 1.1MM DRILL BIT | DRILL BIT | HTW | SYNTHES USA | NA | A6C6898 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Other | 400.736 X 3 -BONE SCREWS. |