FDA Adverse Event
Malfunction
Summary report: N
EXETER CONTEMPORARY RIM CUTTER
MDR report key: 2924062
·
Received December 14, 2012
Report
- Report Number
- 9616680-2012-01389
- Event Type
- Malfunction
- Date Received
- December 14, 2012
- Date of Event
- November 1, 2012
- Report Date
- November 21, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- LXH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NO
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
THE CUSTOMER HAS REPORTED TO THE SALES REP THAT THE RIMCUTTERS SCREW/PIN IN THE GUIDES ARE BENT AND BRAKES DURING SURGERY. TO PROCEED THE SURGERY, THEY USED A DIFFERENT RIMCUTTER WHEN THEY HAVE ADDITIONAL IN THE SAME SIZE AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXETER CONTEMPORARY RIM CUTTER | INSTRUMENT | LXH | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Other |