FDA Adverse Event
Summary report: N
SIZE 2.0 STRYKER DRILL BIT.
MDR report key: 1831760
·
Received August 25, 2010
Report
- Report Number
- 1831760
- Date Received
- August 25, 2010
- Date of Event
- August 24, 2010
- Report Date
- August 26, 2010
- Manufacturer
- STRYKER
- Product Code
- HWE
- Report Source
- User Facility report
- Reporter Location
- MA, US
Narratives
Description of Event or Problem · 1
DURING A SURGICAL PROCEDURE OF PATIENT'S UPPER ARM, WHEN ATTENTION WAS TURNED TO FIXATION OF THE TRICEPS, A DRILL BIT WAS USED TO CREATE HOLES IN THE OLECRANON FOR RE-ATTACHMENT OF THE TRICEPS. DURING THIS TIME, IT WAS NOTED THAT 1 OF THE DRILL BITS BROKE. THIS WAS CONFIRMED WITH THE C-ARM (X-RAY IMAGE INTENSIFIER). THE DRILL WAS NOTED TO HAVE EMERGED ON THE RADIAL SIDE OF THE OLECRANON AND IT WAS IDENTIFIED WITH THE C-ARM AND REMOVED WITH A HEMOSTAT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIZE 2.0 STRYKER DRILL BIT. | INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCES | HWE | STRYKER | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR |