FDA Adverse Event
Malfunction
Summary report: N
EXETER CONTEMPORARY RIM CUTTER
MDR report key: 2903125
·
Received November 30, 2012
Report
- Report Number
- 9616680-2012-01242
- Event Type
- Malfunction
- Date Received
- November 30, 2012
- Date of Event
- November 2, 2012
- Report Date
- November 2, 2012
- Manufacturer
- STRYKER IRELAND, LTD. OSTEONICS (ORTHOPAEDICS DIVI
- Product Code
- JDI
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- 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 HOSPITAL REPORTED THAT THE (B)(4) CANNOT HOLD ANY OF THE (B)(4) (ACETABULAR RIMCUTTER). THE HOSPITAL THINKS IT SEEMS AS IF THERE IS NO LOCK IN (B)(4). THIS HAPPENED DURING SURGERY AND THEY PROCEEDED BY CUTTING OFF AN EDGE OF THE RIMFIT CUP TO AVOID THE NEED OF USING THE RIMCUTTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXETER CONTEMPORARY RIM CUTTER | INSTRUMENT | JDI | STRYKER IRELAND, LTD. OSTEONICS (ORTHOPAEDICS DIVI | NA | G1309656 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |