FDA Adverse Event
Summary report: N
*
MDR report key: 1591411
·
Received January 7, 2010
Report
- Report Number
- 1591411
- Date Received
- January 7, 2010
- Date of Event
- January 4, 2010
- Report Date
- January 7, 2010
- Manufacturer
- SYNTHES (USA) PRODUCTS LLC
- Product Code
- HTW
- Report Source
- User Facility report
- Reporter Location
- CA, US
Narratives
Description of Event or Problem · 1
A (B) (6) MALE WHO UNDERWENT SURGERY FOR A RIGHT DISTAL HUMERUS FRACTURE WITH INTERNAL FIXATION, A RIGHT OLECRANON RE-INJURY FRACTURE, A RIGHT PROXIMAL ULNA OLECRANON FRACTURE WITHOUT INTERNAL FIXATION, AND RIGHT ARM WOUND DEBRIDEMENT. DURING THIS PROCEDURE A PORTION OF A SYNTHES 2.5 DRILL BIT BROKE OFF IN THE MEDIAL COLUMN OF THE RIGHT ARM. THE SURGEON IMMEDIATELY NOTIFIED THE STAFF OF THE BROKEN DRILL BIT. IT WAS DECIDED TO LEAVE THIS PORTION OF THE DRILL BIT IN PLACE DUE TO THE INCREASED RISKS WITH DISSECTION AND POTENTIAL HARM TO THE ELBOW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | DRILL BIT, ORTHOPEDIC | HTW | SYNTHES (USA) PRODUCTS LLC | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR |