FDA Adverse Event
Injury
Summary report: N
NA
MDR report key: 1012668
·
Received March 11, 2008
Report
- Report Number
- 1056128-2008-00014
- Event Type
- Injury
- Date Received
- March 11, 2008
- Date of Event
- February 14, 2008
- Report Date
- March 11, 2008
- Manufacturer
- ASCENT HEALTHCARE SOLUTIONS
- Product Code
- HRX
- PMA / PMN Number
- K012635
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED GALLING MARKS ON THE INNER SHAFT. THESE MARKINGS ARE AN INDICATION THAT THE DEVICE DID EXPERIENCE SIDE-LOADING, THUS CAUSING DISCHARGE OF METAL FRAGMENTS.
Description of Event or Problem · 1
DURING A KNEE ARTHROSCOPY PROCEDURE, THE DEVICE EMITTED METAL FRAGMENTS AND ADDITIONAL IRRIGATION OF THE SURGICAL SITE WAS REQUIRED. NO INJURY TO THE PATIENT OR ADVERSE EVENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NA | HRX | ASCENT HEALTHCARE SOLUTIONS | 375-544-000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |