FDA Adverse Event
Other
Summary report: N
*
MDR report key: 378609
·
Received February 21, 2002
Report
- Report Number
- MW1024146
- Event Type
- Other
- Date Received
- February 21, 2002
- Date of Event
- June 28, 2001
- Report Date
- August 21, 2001
- Manufacturer
- ACUMED INC
- Product Code
- HTT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
WHILE SURGEONS ATTEMPTED TO PERCUTANEOUSLY FIX A WRIST FRACTURE, DRILL BIT AND THE TIP BROKE OFF IN THE PT'S WRIST. THE CASE WAS THEN CHANGED TO AN OPEN CASE TO FIND AND REMOVE THE BROKEN TIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | DRILL BIT | HTT | ACUMED INC | * | AT-7032 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Other |