FDA Adverse Event
Malfunction
Summary report: N
ZIMMER
MDR report key: 2021761
·
Received March 11, 2011
Report
- Report Number
- MW5019810
- Event Type
- Malfunction
- Date Received
- March 11, 2011
- Date of Event
- March 11, 2011
- Report Date
- March 11, 2011
- Manufacturer
- ZIMMER
- Product Code
- HXX
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CO, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
ZIMMER REDUCTION SCREWDRIVER # (B)(4) BROKE WHILE CUTTING BONE. NO HARM TO PT. ALL POLICIES AND PROCEDURES FOLLOWED AS APPROPRIATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIMMER | REDUCTION SCREWDRIVER | HXX | ZIMMER | #3558-2 62 ZE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR |